MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2020-03-20 for PN 32X4 EUROPE BD 320211 manufactured by Becton Dickinson And Co..
[186306159]
Device expiration date: unknown. (b)(6). Device manufacture date: unknown. Investigation summary: no samples or photos were returned for analysis. Investigation conclusion: no dhr review can be carried out as lot number is unknown. Rationale: based on an evaluation of severity and occurrence it was determined that no corrective action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
[186306160]
It was reported that an unspecified number of pn 32x4 europe bd were unable or difficult to prime prior to use. The following information was provided by the initial reporter: product: bd pen needletm 4mm, 320211. Complaint: the customer contacted distributor for medical device supplies. Customer told that in box many of the needles were clogged/insulin did not flow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616656-2020-00250 |
| MDR Report Key | 9862320 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-09 |
| Date of Event | 2019-09-09 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-20 |
| 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 | PN 32X4 EUROPE BD |
| Generic Name | PEN NEEDLE |
| Product Code | FMI |
| Date Received | 2020-03-20 |
| Catalog Number | 320211 |
| Lot Number | UNKNOWN |
| 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 | 2020-03-20 |