MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-19 for BD ULTRA-FINE? NANO? PEN NEEDLES 4MM (5/32?) 32G 2865 320122 manufactured by Becton Dickinson And Co..
[186306520]
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[186306521]
It was reported that an unspecified number of bd ultra-fine? Nano? Pen needles 4mm (5/32? ) 32g were unable to prime and damaged -still operable. The product defects were noted during use. The following information was provided by the initial reporter: material no. 320122 batch no. 9238445. Verbatim: consumer reported - finding the non patient end to be missing after placement onto his pen and during the flow check not working. Lot # 9238445, catalog # 320122, date of event: unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616656-2020-00243 |
| MDR Report Key | 9857454 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-10-15 |
| Date Added to Maude | 2020-03-19 |
| 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? NANO? PEN NEEDLES 4MM (5/32?) 32G |
| Generic Name | HYPODERMIC SINGLE LUMEN NEEDLE |
| Product Code | FMI |
| Date Received | 2020-03-19 |
| Model Number | 2865 |
| Catalog Number | 320122 |
| Lot Number | 9238445 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2020-03-19 |