MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2020-03-20 for PEN NDL 31G 6MM 3B TW 320733 manufactured by Becton Dickinson And Co..
[186722666]
(b)(6). Investigation summary: no samples or photos were returned for analysis. Investigation conclusion: a lot history review was carried out and no related non conformance's were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications. 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
[186722667]
It was reported that an unspecified number of pen ndls 31g 6mm 3b tw experienced a damaged or open unit package/seal where the sterility was compromised. The product defect was noted prior to use. The following information was provided by the initial reporter: product: bd pen needletm 6mm, 320733. Complaint: the customer contacted distributor for medical device supplies. Customer told that in two boxes had needles that were missing the cover.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616656-2020-00248 |
| MDR Report Key | 9861835 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-06-11 |
| 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 | PEN NDL 31G 6MM 3B TW |
| Generic Name | PEN NEEDLE |
| Product Code | FMI |
| Date Received | 2020-03-20 |
| Catalog Number | 320733 |
| Lot Number | 9162558 |
| 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 |