MAUDE Adverse Event Report: BECTON DICKINSON BD ULTRA-FINE¿ INSULIN SYRINGE; PISTON SYRINGE

Catalog Number	329461
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A 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.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.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 while using the bd ultra-fine¿ insulin syringe the cannula breaks off.The following was received from the initial reporter: he said about 1/3 of the syringes he had been using were either bending or breaking when he was trying to inject the insulin into his skin.
Event or Problem Description
It was reported that while using the bd ultra-fine¿ insulin syringe the cannula breaks off.The following was received from the initial reporter: he said about 1/3 of the syringes he had been using were either bending or breaking when he was trying to inject the insulin into his skin.
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.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 ULTRA-FINE¿ INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• 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: 18022773
• Report Number: 2243072-2023-01958
• Device Sequence Number: 20773346
• Product Code: FMF
• UDI-Device Identifier: 30382903294610
• UDI-Public: (01)30382903294610
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K190054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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 Catalogue Number: 329461
• Device Lot Number: UNKNOWN
• 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: 10/19/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 11/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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