MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-17 for PEN NDL 32G 4MM HP 100 BOX 1200 US 320550 manufactured by Becton Dickinson And Co..
[186311170]
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[186311171]
It was reported that pen ndl 32g 4mm hp 100 box 1200 us tear drop label was loose and exposed the needle. This was discovered before use. The following information was provided by the initial reporter: material no. : 320550 batch no. : 9162545. It was reported in a phone call that the green piece kept falling off which the customer said was dangerous as it exposed the needle. Verbatim: it was reported in a phone call that the green piece kept falling off which the customer said was dangerous as it exposed the needle. Added on 03/04/2020 update called this consumer back - claims spoke with someone who is sending a mailing kit and replacement. Consumer reported the inner needle shield fell off when removed the outer cover from the pen needle, making it a hazard to her. She was not stuck with the needle. Claims just purchased several boxes of this item number. Just tried this one box..
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616656-2020-00236 |
| MDR Report Key | 9842732 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-06-11 |
| Date Added to Maude | 2020-03-17 |
| 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 HP 100 BOX 1200 US |
| Generic Name | PEN NEEDLE |
| Product Code | NSC |
| Date Received | 2020-03-17 |
| Model Number | 320550 |
| Catalog Number | 320550 |
| Lot Number | 9162545 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-17 |