MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-23 for SYRINGE 3ML 25G 5/8" L/L 9570 manufactured by Bd.
[184851800]
Solicited call from pt reporting that one of the 4 syringes sent last shipment was defective. No further info was reported. Lot number and exp date unk. Unk if pt experienced an adverse event due to the defective product. Unk if pt has the product on-hand. Reported to (b)(6) by pt/caregiver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093893 |
| MDR Report Key | 9871605 |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-19 |
| Date Added to Maude | 2020-03-24 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYRINGE 3ML 25G 5/8" L/L 9570 |
| Generic Name | SYRINGE, PISTON |
| Product Code | FMF |
| Date Received | 2020-03-23 |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD |
| Product Code | --- |
| Date Received | 2020-03-23 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |