MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD CONVENTIONAL NEEDLES; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 301643

Device Problem Defective Component (2292)

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

Event Date 08/10/2023

Event Type  malfunction  

Manufacturer Narrative

H.6.It was reported pieces have deformed cannula tips.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos show a bent needle with a flat tip.The conditions of the needle shown in the photos does not represent how the unit leave the manufacturing site.No other information could be obtained from the photos.A device history record review was completed for provided material number 301643, lot 2200730.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed.To provide a probable root cause, the physical sample analysis would be required.We appreciate you taking the time to bring this observation to our attention.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.H3 other text : see h.10.

Event Description

It was reported that bd conventional needles were cracked.The following information was received by the initial reporter with the verbatim: we want to inform you of the following deviation identified during processing of lot 2200730 of material 301643 observed with damaged tips.Description of event: on (b)(6) 2023, during the qc visual inspection, qc technician found 2 of 50 pieces (normal inspection) to have deformed cannula tips.Non-conformances were confirmed by lead qc technicians.This production batch used component batch 15cr8x of material 300030262, cannula, blunt, 27 ga x 1 (05-8020), which is received from becton dickinson and company (supplier# (b)(6)).

• Brand Name: BD CONVENTIONAL NEEDLES
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17844600
• MDR Text Key: 324603643
• Report Number: 1911916-2023-00709
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903016433
• UDI-Public: (01)00382903016433
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301643
• Device Lot Number: 2200730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• 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