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

Model Number	328235
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is nypro.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.E1: initial reporter e-mail: (b)(6).D.4 device expiration date: na h3.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 that the bd safe-clip¿ is no longer clipping.The following information was provided by the initial reporter, translated from (b)(6) to english: the needle cutter no longer cuts me.
Event or Problem Description
It was reported that the bd safe-clip¿ is no longer clipping.The following information was provided by the initial reporter, translated from spanish to english: the needle cutter no longer cuts me.
Additional Manufacturer Narrative
H6: investigation summary no samples were returned therefore the complaint could not be confirmed and the root cause is undetermined.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD SAFE-CLIP¿
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17234413
• Report Number: 2243072-2023-01153
• Device Sequence Number: 20667202
• Product Code: FMI
• UDI-Device Identifier: 00382903282357
• UDI-Public: (01)00382903282357
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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
• Operator of Device: Other
• Device Model Number: 328235
• Device Catalogue Number: 328235
• Device Lot Number: 2047001
• 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: 06/09/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 09/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• 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