MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-19 for PEN NDL 31G 8MM 90 COUNT MAIL ORDER ONLY 8300 320881 manufactured by Becton Dickinson And Co..
[186306682]
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: not applicable as no sample is returned for evaluation. Investigation conclusion: the complaint is unconfirmed as no photo / samples of the reported batch were received. Root cause description: a review of past 12 months quality notification was performed, and no quality notification was raised on the reported defects. The complaint is unconfirmed as no photo / samples of the reported batch were received. Therefore, root cause could not be determined. The complaint will be re-opened and re-investigated if the photo / sample is returned. Rationale: the complaint is unconfirmed as no photo / samples of the reported batch were received.
Patient Sequence No: 1, Text Type: N, H10
[186306683]
It was reported that pen ndl 31g 8mm 90 count mail order only was bent during use. The following information was provided by the initial reporter: "consumer reported needle pain during injection, needles bend at patient end before injection, needle leaks after injection. Consumer does not re-use, does rotate injection site, stated that he leaves the needle in place for at least 10 seconds before removing from the injection site. Samples were discarded. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616656-2020-00244 |
| MDR Report Key | 9857678 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-01-03 |
| 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 | PEN NDL 31G 8MM 90 COUNT MAIL ORDER ONLY |
| Generic Name | HYPODERMIC SINGLE LUMEN NEEDLE |
| Product Code | FMI |
| Date Received | 2020-03-19 |
| Model Number | 8300 |
| Catalog Number | 320881 |
| Lot Number | 8263491 |
| 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 |