MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for INSYTE AUTOGUARD 882544 manufactured by Becton Dickinson.
[185707844]
Catheter on iv angiocath bent at the tip. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093963 |
| MDR Report Key | 9897291 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-24 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | RISK MANAGER |
| 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 | INSYTE AUTOGUARD |
| Generic Name | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS |
| Product Code | FOZ |
| Date Received | 2020-03-27 |
| Catalog Number | 882544 |
| Lot Number | 9331186 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |