MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-02-27 for NEEDLE FILTER BLUNT FILL 18X1-1/2 305211 manufactured by Becton Dickinson And Company.
[187222711]
Investigation summary: 1 sample was received. It came in sealed packaging blister. The lot# printed on is the lot# 9163721. The top and bottom webs are fully sealed making difficult to separate them and open the packaging blister. 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. Investigation conclusion: this is the 1st complaint for lot # 9163721 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: 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.
Patient Sequence No: 1, Text Type: N, H10
[187222712]
It was reported that package issues were found before use with needle filter blunt fill 18x1-1/2. The following information was provided by the initial reporter, "the customer informs that several eaches in a box of blunt fill needle with filter have an issue with the gluing of the package. The edges of the packet are glued all the way, so that it is impossible to open the package in a sterile manner. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00194 |
| MDR Report Key | 9766008 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2019-06-12 |
| Date Added to Maude | 2020-02-27 |
| 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 COMPANY |
| Manufacturer Street | 2153 12TH 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 | NEEDLE FILTER BLUNT FILL 18X1-1/2 |
| Generic Name | MANUAL SURGICAL INSTRUMENT FOR GENERAL USE |
| Product Code | GAA |
| Date Received | 2020-02-27 |
| Returned To Mfg | 2020-02-26 |
| Model Number | 305211 |
| Catalog Number | 305211 |
| Lot Number | 9163721 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON AND COMPANY |
| Manufacturer Address | 2153 12TH AVENUE COLUMBUS NE 68601 US 68601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-27 |