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

Model Number	328235
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
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.D.4.Medical device expiration date: na.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 that during use with bd safe-clip¿ needle clipping and storage device the device is not operating correctly, it will not "spring back" in ready position after use.The following information was provided by the initial reporter: consumer stated, once he clips the needle, the device will not "spring back" in a ready position to use again.Stated, he has to push it back with his hand so its ready to use again.
Event or Problem Description
It was reported that during use with bd safe-clip¿ needle clipping and storage device the device is not operating correctly, it will not "spring back" in ready position after use.The following information was provided by the initial reporter: consumer stated, once he clips the needle, the device will not "spring back" in a ready position to use again.Stated, he has to push it back with his hand so its ready to use again.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 04-aug-2023.Customer returned (1) used bd safeclip from the unknown lot#.It was reported by the consumer that once he clips the needle, the device will not "spring back" in a ready position to use again.The safeclip visually examined and observed no damages.Functionality test was performed and no difficulty was observed during clipping the needles.The device worked as intended.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.H3 other text : see h10.

• Brand Name: BD SAFE-CLIP¿ NEEDLE CLIPPING AND STORAGE 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17322411
• Report Number: 2243072-2023-01227
• Device Sequence Number: 5523619
• Product Code: FMI
• UDI-Device Identifier: 00382903282357
• UDI-Public: (01)00382903282357
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/28/2023

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: 2194001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 10/11/2023
• 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