MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-10-29 for BD I.V. START PAK WITH BD PERSIST SKIN PREP 386702 manufactured by Bd.
[3951681]
On (b)(6) 2013, the reporter stated that the nurse in the emergency department had a severe allergic reaction after using the i. V. Start pack for the first time. She went home after the incident and the reaction worsened and she needed to be treated with adrenalin at (b)(6). She has since been on sick leave and referred to a dermatologist to try to identify what in the pack caused the reaction. It has not yet been confirmed if gloves were worn or if the nurse had any skin exposure to the persist plus solution.
Patient Sequence No: 1, Text Type: D, B5
[11373942]
No product return is anticipated as complaint indicates that there is no samples. Unable to run complaint history check or device history review as lot number is unknown. Quality will continue to monitor on monthly trend reports.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243072-2013-00151 |
| MDR Report Key | 3445250 |
| Report Source | 01,07 |
| Date Received | 2013-10-29 |
| Date of Report | 2013-10-29 |
| Date of Event | 2013-10-07 |
| Date Mfgr Received | 2013-10-07 |
| Date Added to Maude | 2013-11-05 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH CLOSNER, RN, BSN |
| Manufacturer Street | 1 BECTON DR. |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal | 07417 |
| Manufacturer Phone | 2105265165 |
| Manufacturer G1 | BD MEDICAL INFUSION THERAPY SYSTEMS |
| Manufacturer Street | BLVD LUIS DONALDO COLOSIO #3100 |
| Manufacturer City | NOGALES, SONORA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD I.V. START PAK WITH BD PERSIST SKIN PREP |
| Generic Name | I.V. START PAK |
| Product Code | LRS |
| Date Received | 2013-10-29 |
| Catalog Number | 386702 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD |
| Manufacturer Address | 1 BECTON DR. FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-10-29 |