MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for BD INSYTE AUTOGUARD 382544 manufactured by Becton, Dickinson And Company.
[185223579]
As nurse was going to place the iv in the patient, she found the iv catheter was split at the end prior to placing it in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9888557 |
| MDR Report Key | 9888557 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-03-10 |
| Report Date | 2020-03-11 |
| Date Reported to FDA | 2020-03-11 |
| Date Reported to Mfgr | 2020-03-27 |
| Date Added to Maude | 2020-03-27 |
| 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 INSYTE AUTOGUARD |
| Generic Name | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS |
| Product Code | FOZ |
| Date Received | 2020-03-27 |
| Model Number | 382544 |
| Catalog Number | 382544 |
| Lot Number | 9316117 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-27 |