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 2020-03-18 for NEEDLE NS 30GA 1/2IN BNS YEL HUB TW EURO 302047 manufactured by Bd Medical (bd West) Medical Surgical.
[186324937]
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Investigation summary: one photo was provided. It shows two needle assemblies without the plastic shield. One has the needle with normal finishing/ color; the other is blackened. The etching cannula may had a variation creating this unit with discoloration. 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 complaints for the lot # 8204928 for the same defect or symptom. There was no documentation for this type of defects during the entire production run of this batch. Root cause description: cannula process. The etching cannula may had a variation creating this unit with discoloration. Rationale: capa required not this time.
Patient Sequence No: 1, Text Type: N, H10
[186324938]
It was reported that needle ns 30ga 1/2in bns yel hub tw euro contained foreign matter. The following information was provided by the initial reporter: "blackened needles were founded in the visual inspection blackened 10 needles / 500 needles inspected (2%). "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00271 |
| MDR Report Key | 9850776 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2018-07-23 |
| Date Added to Maude | 2020-03-18 |
| 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 | NEEDLE NS 30GA 1/2IN BNS YEL HUB TW EURO |
| Generic Name | NEEDLE |
| Product Code | FMI |
| Date Received | 2020-03-18 |
| Catalog Number | 302047 |
| Lot Number | 8204928 |
| 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 | 2020-03-18 |