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 2020-03-03 for BD NOKOR? FILTER NEEDLE 305200 manufactured by Bd Medical (bd West) Medical Surgical.
[187218231]
Investigation summary: 2 photos were provided. One photo shows no sealed packaging blisters from the bottom. The other photo shows the same packaging blisters from the top web. They have highlighted with a handwritten circle the middle of the packaging where it has the 19x 1-?? Tw text is. Part of the text is incomplete or missing. 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. Investigation conclusion: confirmed: bd was able to duplicate or confirm the customer's indicated failure mode with the photos provided. This is the 1st complaint for lot # 8236650 for this type of defect or symptom. There was no documentation for this type of defect during the entire production run of this batch. Root cause description: it could have happened during the multivac packaging top web printing process and was not detected in the next processes. Rationale: capa not required at this time.
Patient Sequence No: 1, Text Type: N, H10
[187218232]
It was reported that the bd nokor? Filter needle had "unclear specifications and models" found in the printed label before use while conducting a box opening inspection. The following information was provided by the initial reporter, translated from chinese to english: "on february 17th, 2020, the company conducted box opening inspection on 8326650 batches of disposable filter needles, a total of 2,500 filter needles were tested, and a total of 199 products were found to have unclear specifications and models in label printing. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00209 |
| MDR Report Key | 9781743 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2018-10-23 |
| Date Added to Maude | 2020-03-03 |
| 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 NOKOR? FILTER NEEDLE |
| Generic Name | MANUAL SURGICAL INSTRUMENT FOR GENERAL USE |
| Product Code | GAA |
| Date Received | 2020-03-03 |
| Model Number | 305200 |
| Catalog Number | 305200 |
| Lot Number | 8236650 |
| Device Availability | N |
| 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 | 2020-03-03 |