MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2019-08-12 for PEN NEEDLE 31GX5MM 7 PACK 329487 manufactured by Bd (suzhou).
| Report Number | 3006948883-2019-00645 |
| MDR Report Key | 8883758 |
| Report Source | CONSUMER,FOREIGN,OTHER |
| Date Received | 2019-08-12 |
| Date of Report | 2019-08-21 |
| Date of Event | 2019-07-27 |
| Date Mfgr Received | 2019-07-28 |
| Device Manufacturer Date | 2019-01-21 |
| Date Added to Maude | 2019-08-12 |
| 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 |
| 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 | BD (SUZHOU) |
| Manufacturer Street | NO. 5 BAIYU ROAD SUZHOU INDUSTRIAL PARK |
| Manufacturer City | SUZHOU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEN NEEDLE 31GX5MM 7 PACK |
| Generic Name | PEN NEEDLE |
| Product Code | NSC |
| Date Received | 2019-08-12 |
| Catalog Number | 329487 |
| Lot Number | 8184315 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD (SUZHOU) |
| Manufacturer Address | NO. 5 BAIYU ROAD SUZHOU INDUSTRIAL PARK SUZHOU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-12 |