MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-27 for DELTEC? PORT-A-CATH?II IMPLANTABLE ACCESS SYSTEM 21-4063-24 manufactured by Smiths Medical Asd; Inc..
[185197048]
Information was received indicating that a physician was unable to draw blood from a smiths medical deltec? Port-a-cath? Ii implantable access system. The patient was then sent to the hospital for a port check and was observed to have extravasation to the left clavicle region under fluoroscopy. Subsequently, the port was explanted, discarded and replaced with a new one in interventional radiology. There were no further reported adverse patient effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02167 |
| MDR Report Key | 9887343 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-10-28 |
| Date Added to Maude | 2020-03-27 |
| 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 N |
| Manufacturer City | MINNEAPOLIS,, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 3350 GRANADA AVENUE NORTH SUITE 100 |
| Manufacturer City | OAKDALE, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DELTEC? PORT-A-CATH?II IMPLANTABLE ACCESS SYSTEM |
| Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
| Product Code | LJT |
| Date Received | 2020-03-27 |
| Model Number | 21-4063-24 |
| Catalog Number | 21-4063-24 |
| Lot Number | 3885548 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD; INC. |
| Manufacturer Address | 6000 NATHAN LANE N MINNEAPOLIS,, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-27 |