MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for BD INSYTE AUTOGUARD 382544 manufactured by Becton, Dickinson And Company.
[184867220]
Patient care technician was removing this patient's iv as he was being discharged. Upon removal, they observed that the tip of the iv was missing a small piece. The physician was called and ordered a ultrasound of the patient's arm to be done. There was no echogenic material seen in the vein but there was a nonocclusive mural thrombus. This iv was placed on [date redacted]. We do not know the lot number as the packaging was not saved, but on the dressing which we believe is the original dressing, has the numbers (b)(4) on the tape.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9876945 |
| MDR Report Key | 9876945 |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-20 |
| Report Date | 2020-02-21 |
| Date Reported to FDA | 2020-02-21 |
| Date Reported to Mfgr | 2020-03-25 |
| Date Added to Maude | 2020-03-25 |
| 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 | 2020-03-25 |
| Model Number | 382544 |
| Catalog Number | 382544 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND COMPANY |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |