MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-30 for BD? BLUNT FILTER NEEDLE 305211 manufactured by Bd Medical (bd West) Medical Surgical.
[144457045]
Date of event: unknown. (b)(6). 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
[144457046]
It was reported that bd? Blunt filter needle had foreign matter on the needle tip. No serious injury or medical intervention was reported. The following information was provided by the initial reporter: when removed the cap, fm like dust was on the needle tip. Replaced by new product. Lot# is 7236772 or 7236779.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2019-00423 |
| MDR Report Key | 8566219 |
| Date Received | 2019-04-30 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-04-15 |
| Date Mfgr Received | 2019-04-15 |
| Device Manufacturer Date | 2018-04-09 |
| Date Added to Maude | 2019-04-30 |
| 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 | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Street | 1852 10TH AVENUE |
| Manufacturer City | COLUMBUS NE 68601 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68601 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD? BLUNT FILTER NEEDLE |
| Generic Name | FILTER NEEDLE |
| Product Code | FPB |
| Date Received | 2019-04-30 |
| Returned To Mfg | 2019-04-17 |
| Catalog Number | 305211 |
| Lot Number | SEE H.10 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Address | 1852 10TH AVENUE COLUMBUS NE 68601 US 68601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-30 |