MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for BD INTROSYTE-N, BD INSTAFLASH 384021 manufactured by Becton, Dickinson And Company.
[185711393]
From staff: during picc placement, when the introducer was removed and attempted to peel away the cannula, it would not peel and then the wing broke off. While attempting to remove the cannula after the wing broke, the catheter was punctured and had to be removed and new one needed to be placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9902745 |
| MDR Report Key | 9902745 |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-03-14 |
| Report Date | 2020-03-19 |
| Date Reported to FDA | 2020-03-19 |
| Date Reported to Mfgr | 2020-03-31 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD INTROSYTE-N, BD INSTAFLASH |
| Generic Name | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS |
| Product Code | FOZ |
| Date Received | 2020-03-31 |
| Model Number | 384021 |
| Catalog Number | 384021 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND COMPANY |
| Manufacturer Address | ONE BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |