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 2020-03-17 for BD ULTRA-FINE? PEN NEEDLE 320144 manufactured by Becton Dickinson And Co..
[186308921]
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
[186308922]
It was reported that bd ultra-fine? Pen needle clogged during use. The following information was provided by the initial reporter: material no. 320144 batch no. 9141570. It was reported that needle clogged during priming and needle was bent at non patient end before injection. Verbatim: consumer reported needle clog during priming, and needle bent at non patient end before injection. Does not re-use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616656-2020-00238 |
| MDR Report Key | 9843725 |
| Report Source | CONSUMER,FOREIGN,OTHER |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-05-21 |
| 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 | BD ULTRA-FINE? PEN NEEDLE |
| Generic Name | PEN NEEDLE |
| Product Code | NSC |
| Date Received | 2020-03-17 |
| Catalog Number | 320144 |
| Lot Number | 9141570 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| 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 | 2020-03-17 |