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 2020-03-10 for BD BLUNT FILL NEEDLE WITH FILTER 305211 manufactured by Bd Medical (bd West) Medical Surgical.
[187217765]
Date of event: unknown. The date received by manufacturer has been used for this field. Initial reporter phone #: unknown. Investigation summary: the photo provided show two needle assemblies with the packaging blister torn while opening it. This would have happened during the multivac packaging process. The bottom web is formed to create a kind of nest and the part is placed in the "nest". Then the top web is placed, and the blister is sealed. In this case both webs were fully sealed and not detected during the inspections. 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 record review was completed with zero defects found. No quality notifications were written for this batch, nor for the associated assembly batches. This is the 1st complaint for lot # 8047737 for this type of defect or symptom. Root cause description: it could have happened during multivac packaging process. Rationale: capa not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[187217766]
It was reported that during use the outer packaging does not separate with a bd blunt fill needle with filter. The following information was provided by the initial reporter, translated from (b)(6) to english: our customer complained that the paper of the outer packaging does not completely separate from the plastic when two filter cannulas are used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00227 |
| MDR Report Key | 9810410 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER |
| Date Received | 2020-03-10 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2018-02-16 |
| Date Added to Maude | 2020-03-10 |
| 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 | 3 |
| Brand Name | BD BLUNT FILL NEEDLE WITH FILTER |
| Generic Name | MANUAL SURGICAL INSTRUMENT FOR GENERAL USE |
| Product Code | GAA |
| Date Received | 2020-03-10 |
| Model Number | 305211 |
| Catalog Number | 305211 |
| Lot Number | 8047737 |
| 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 | 2020-03-10 |