MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-09-03 for PEN NDL 32G 4MM PRO 100 BOX AP 320566 manufactured by Becton Dickinson And Co..
| Report Number | 9616656-2019-00817 |
| MDR Report Key | 8955853 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-09-03 |
| Date of Report | 2019-09-09 |
| Date of Event | 2019-08-14 |
| Date Mfgr Received | 2019-08-14 |
| Device Manufacturer Date | 2019-01-15 |
| Date Added to Maude | 2019-09-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON DICKINSON AND CO. |
| Manufacturer Street | POTTERY ROAD |
| Manufacturer City | DUN LAOGHAIRE CO |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEN NDL 32G 4MM PRO 100 BOX AP |
| Generic Name | PEN NEEDLE |
| Product Code | NSC |
| Date Received | 2019-09-03 |
| Returned To Mfg | 2019-08-26 |
| Catalog Number | 320566 |
| Lot Number | 9015921 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON AND CO. |
| Manufacturer Address | POTTERY ROAD DUN LAOGHAIRE CO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-03 |