MAUDE Adverse Event Report: BECTON DICKINSON BD SAFE-CLIP¿ NEEDLE CLIPPING DEVICE; 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	06/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.As nypro, mx is an oem manufacturing site.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical 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¿ needle clipping and storage device not clipping.The following information was provided by the initial reporter: consumer reported the bd safeclip is not clipping.
Event or Problem Description
It was reported that the bd safe-clip¿ needle clipping and storage device not clipping.The following information was provided by the initial reporter: consumer reported the bd safeclip is not clipping.
Additional Manufacturer Narrative
Investigation summary customer returned (1) used bd safeclip from the lot# 2179001.It was reported by the consumer that bd safeclip is not clipping.The safeclip visually examined and observed no damages.It was observed that the cutter hole was blocked with previously clipped cannula additional cannula could not be inserted into the receptacle due to the blockage.The likely scenario is that the safe clip is full, has been used over time, and there is no room to store additional cannula.This usually results after normal use of the product and is therefore not confirmed as a defect.At this point the user should dispose the safe clip correctly as he or she would for any full sharps collector/container.A device history record review showed no non-conformances associated with this issue during the production of this batch.Bd was not able to duplicate or confirm the customer¿s indicated failure as the device performed as intended and is now likely full.The cause for this issue is user related.The safeclip performed as intended, and is now likely full.

• 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: 17367817
• Report Number: 2243072-2023-01282
• Device Sequence Number: 6211463
• Product Code: FMI
• UDI-Device Identifier: 00382903282357
• UDI-Public: (01)00382903282357
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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: Lay User/Patient
• Device Model Number: 328235
• Device Catalogue Number: 328235
• Device Lot Number: 2179001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• 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