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 2020-03-16 for BD BLUNT FILL NEEDLE WITH FILTER 305211 manufactured by Bd Medical (bd West) Medical Surgical.
[188345707]
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary nine photos were provided showing top web of a product. They also show what appears a needle hub or cap, blue color, it is damaged. This part doesn? T belong to a needle assembly filter blunt fill. It is unknown the origin of the parts and top web shown. Root cause is undetermined. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. A device history review could not be completed as no batch number was provided.
Patient Sequence No: 1, Text Type: N, H10
[188345708]
It was reported that before use of the bd blunt fill needle with filter there was an issue with foreign matter. The following information was provided by the initial reporter: they have used 2 bd needles to inject medication into the bag: bd microlance ref. 304622 and bd blunt filter needle ref. 305211. They have not got the lot numbers for these products as the incident happened 2? 3 weeks ago. This is an event received on 17 february 2020 by mail from (b)(6) regarding 1 bag numeta g19e (product code kdb9623, lot nr 19j28n40) with particulate matter. The customer observed a hard blue fragment in the content of the bag after addition of additives. Sample photo was attached. The customer cut the bag open and found the blue insertion tip. The fragment is needle shaped and felt hard when pressing on the bag. Whether the fragments came from the tip or from the inner membrane of the injection port is unknown. Occurrence date was unknown. No patient involved. Sample photo is only available as the product has been adulterated and discarded by customer. Further information (lot nr, syringe used for additives) requested from customer. Added 28 february 2020: customer uses blunt fill syringe 5 um from becton dickinson.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2020-00398 |
| MDR Report Key | 9836585 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-16 |
| 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 |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD BLUNT FILL NEEDLE WITH FILTER |
| Generic Name | MANUAL SURGICAL INSTRUMENT FOR GENERAL USE |
| Product Code | GAA |
| Date Received | 2020-03-16 |
| Model Number | 305211 |
| Catalog Number | 305211 |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-16 |