MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ BLUNT FILL NEEDLE; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number 305180

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: it was reported a blunt needle was protruding from the packaging.To aid in the investigation, one photo was provided for evaluation by our quality team.Each photo shows a strip of five packaging blisters.One photo shows of the packaging blisters has two needles assemblies instead of one.In the second photo the packaging blister has the needle partially out of the packaging blister.No other defects or imperfections were observed.This defect could occur if the feeder misfed sending an additional unit into the packaging blister.A device history record review was completed for provided material number 305180, lot number 1095832.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the feeding system was performed.The settings were correct and the flow of product was good.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.

Event Description

It was reported that the unit package was damaged on the bd¿ blunt fill needle.The following information was provided by the initial reporter: needle protruding from packing.

• Brand Name: BD¿ BLUNT FILL NEEDLE
• Type of Device: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14758140
• MDR Text Key: 294528512
• Report Number: 1911916-2022-00308
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 00382903051809
• UDI-Public: 00382903051809
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305180
• Device Lot Number: 1095832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1