MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-03-31 for PEN NEEDLE 31X8 ASIA 320471 manufactured by Bd (suzhou).
[187102834]
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[187102835]
It was reported that pen needle 31x8 asia bent and broke off during use. This occurred on 5 occasions. The following information was provided by the initial reporter: needle bending and breaking from the hub. The patient reported that she was switched to the bd micro-fine 8mm pen needle by the pharmacist when the novo 8mm was out of stock. She self injected on monday 9th march at 5 pm. When the injection was completed she pulled out the needle and noticed that the needle was missing from the hub. The needle had broken off and was stuck below the skin. She went to see her local gp about the missing needle and was sent for an ultrasound to find exactly where the needle was located. When the needle was located she had to go into a procedure to remove the needle. The procedure took 45 minutes and it left her with 3-4 stitches. The procedure was this morning. She has kept the broken needle and is happy to return the sample. She also reported that she had noticed some of the needles had bent after an injection. She is happy to return samples of the pen needle from this batch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006948883-2020-00106 |
| MDR Report Key | 9906789 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-31 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2019-07-08 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BD (SUZHOU) |
| Manufacturer Street | NO. 5 BAIYU ROAD SUZHOU INDUSTRIAL PARK |
| Manufacturer City | SUZHOU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEN NEEDLE 31X8 ASIA |
| Generic Name | PEN NEEDLE |
| Product Code | FMI |
| Date Received | 2020-03-31 |
| Catalog Number | 320471 |
| Lot Number | 9064681 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD (SUZHOU) |
| Manufacturer Address | NO. 5 BAIYU ROAD SUZHOU INDUSTRIAL PARK SUZHOU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |