MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-20 for SYRINGE, BARD, IRRIGATION 0035280 * manufactured by Bard.
[15860486]
A hair was found in the sterile syringe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2633289 |
| MDR Report Key | 2633289 |
| Date Received | 2012-06-20 |
| Date of Report | 2012-06-20 |
| Date of Event | 2012-06-07 |
| Report Date | 2012-06-20 |
| Date Reported to FDA | 2012-06-20 |
| Date Added to Maude | 2012-06-28 |
| 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 | 0 |
| 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, BARD, IRRIGATION |
| Generic Name | ASEPTO SYRINGE |
| Product Code | EYN |
| Date Received | 2012-06-20 |
| Model Number | 0035280 |
| Catalog Number | * |
| Lot Number | NGWD3221 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD |
| Manufacturer Address | 8195 INDUSTRIAL BOULEVARD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-20 |