MAUDE Adverse Event Report: BECTON DICKINSON BD SAFE-CLIP¿ NEEDLE CLIPPING DEVICE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	328235
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the initial reporter that the bd safe-clip¿ needle clipping device was not clipping.The following was received by the initial reporter: needle clippers (lot#3003001) patient obtained from retail pharmacy approx 2-3 months ago are not cutting needle tips off as per design.Seems to be bending the tip, sometimes breaking it through bending force, other times not at all.Also seems to be a needle tip jammed inside needle entry point of clippers (unable to remove).
Additional Manufacturer Narrative
Oem manufacturer:the manufacturing location for this product is [flextronics].This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported by the initial reporter that the bd safe-clip¿ needle clipping device was not clipping.The following was received by the initial reporter: needle clippers (lot#3003001) patient obtained from retail pharmacy approx 2-3 months ago are not cutting needle tips off as per design.Seems to be bending the tip, sometimes breaking it through bending force, other times not at all.Also seems to be a needle tip jammed inside needle entry point of clippers (unable to remove).
Additional Manufacturer Narrative
H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• Brand Name: BD SAFE-CLIP¿ NEEDLE CLIPPING DEVICE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 18341408
• Report Number: 2243072-2023-02194
• Device Sequence Number: 20532446
• Product Code: FMI
• UDI-Device Identifier: 00382903282357
• UDI-Public: (01)00382903282357
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K943683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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
• Operator of Device: Other
• Device Catalogue Number: 328235
• Device Lot Number: 3003001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown