MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-10 for SMITHS MEDICAL MEDEX INFUSION EXTENSION SETS AND DISPOSABLES MX448HL60 manufactured by Smiths Medical Asd, Inc..
[144745720]
One infusion extension set was returned for evaluation. Sample underwent functional testing to detect for leakage. No leakage was observed, therefore customer reported complaint was not confirmed. While no definitive problem source to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.
Patient Sequence No: 1, Text Type: N, H10
[144745721]
Information was received that while a smiths medical infusion extension set was in use in the nicu, it was noted to be leaking at the connection. It was noted to be about 8 cm x 10 cm area. A piv was placed, as well as labs drawn for complete blood count. Hematocrit was reported to have dropped from 42 to 30, and red blood cells were ordered to be transfused. The pharmacy was notified to send stat total parental nutrition for piv.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-02584 |
| MDR Report Key | 8601171 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-10 |
| Date of Report | 2019-05-10 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2019-02-25 |
| Date Added to Maude | 2019-05-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 6250 SHIER RINGS ROAD |
| Manufacturer City | DUBLIN OH 43016 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 43016 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMITHS MEDICAL MEDEX INFUSION EXTENSION SETS AND DISPOSABLES |
| Generic Name | TUBING, FLUID DELIVERY |
| Product Code | FPK |
| Date Received | 2019-05-10 |
| Returned To Mfg | 2019-03-20 |
| Catalog Number | MX448HL60 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-10 |