MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-27 for BD IV START PAK W/PERSIST, TEGADERM 386170 manufactured by Bd Infusion Therapy Systems Inc. S.a. De C.v..
| Report Number | 9610847-2019-00433 |
| MDR Report Key | 8739516 |
| Date Received | 2019-06-27 |
| Date of Report | 2019-08-16 |
| Date of Event | 2019-06-11 |
| Date Mfgr Received | 2019-06-11 |
| Device Manufacturer Date | 2018-06-15 |
| Date Added to Maude | 2019-06-27 |
| 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 |
| 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 INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. |
| Manufacturer Street | PERIFERICO LUIS DONALDO COLOSIO NO. 579 |
| Manufacturer City | NOGALES |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD IV START PAK W/PERSIST, TEGADERM |
| Generic Name | IV START KIT |
| Product Code | LRS |
| Date Received | 2019-06-27 |
| Catalog Number | 386170 |
| Lot Number | 8148544 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. |
| Manufacturer Address | PERIFERICO LUIS DONALDO COLOSIO NO. 579 NOGALES US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-27 |