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	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd safe-clip¿ was jammed and not clipping.The following information was provided by the initial reporter: consumer reported, safeclip is not clipping.
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.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4 device expiration date: unknown.H.4.Device manufacture date: unknown.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.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.
Event or Problem Description
It was reported that the bd safe-clip¿ was jammed and not clipping.The following information was provided by the initial reporter: consumer reported, safeclip is not clipping.
Additional Manufacturer Narrative
The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 30-jun-2023 investigation summary customer returned (1) used bd safeclip without lot#.It was reported by the consumer that 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.Unable to perform dhr review results check for not clipping due to unknown lot number.Bd was not able to duplicate or confirm the customer¿s indicated failure as the device performed as intended and is now likely full.

• 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: 17211765
• Report Number: 2243072-2023-01132
• Device Sequence Number: 6495079
• Product Code: FMI
• UDI-Device Identifier: 00382903282357
• UDI-Public: (01)00382903282357
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/25/2023

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: UNKNOWN
• 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: 06/01/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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