MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-05 for BD IV START PAK? SITE PREP KIT WITH BD PERSIST? SKIN PREP, TEGADERM? DRESSING 386170 manufactured by Bd Infusion Therapy Systems Inc. S.a. De C.v..
[126436116]
(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[126436117]
It was reported with the use of the bd iv start pak? Site prep kit with bd persist? Skin prep, tegaderm? Dressing there was an issue with leakage. There was no report of injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610847-2018-00363 |
| MDR Report Key | 8039304 |
| Date Received | 2018-11-05 |
| Date of Report | 2019-01-25 |
| Date of Event | 2018-10-16 |
| Date Mfgr Received | 2018-10-16 |
| Device Manufacturer Date | 2018-04-09 |
| Date Added to Maude | 2018-11-05 |
| 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 | 8015652845 |
| 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? SITE PREP KIT WITH BD PERSIST? SKIN PREP, TEGADERM? DRESSING |
| Generic Name | IV START KIT |
| Product Code | LRS |
| Date Received | 2018-11-05 |
| Catalog Number | 386170 |
| Lot Number | 8086942 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-11-05 |