MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE; PISTON SYRINGE

Catalog Number	928856
Medical Device Problem Codes	Failure to Deliver (2338); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 while using the bd ultra-fine¿ insulin syringe the plunger would not move and unable to deliver medication.The following was received by the initial reporter: this 1 syringe was filled about 30mts before he attempted to use and found the plunger would not move.Infomed caller not to prefill and complete injections right after filling.I had a catstophe happen with a syringe purchased at your xxx.I was going out to eat and loaded syringes to take with me.During breakfast one syringe refused to inject, the pump refused to inject no matter how hard i pushed.
Additional Manufacturer Narrative
H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 1242591.All inspections and challenges were performed per the applicable operations qc specification.H3 other text : see h10.
Event or Problem Description
It was reported while using the bd ultra-fine¿ insulin syringe the plunger would not move and unable to deliver medication.The following was received by the initial reporter: this 1 syringe was filled about 30mts before he attempted to use and found the plunger would not move.Infomed caller not to prefill and complete injections right after filling.I had a catstophe happen with a syringe purchased at your xxx.I was going out to eat and loaded syringes to take with me.During breakfast one syringe refused to inject, the pump refused to inject no matter how hard i pushed.

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17547262
• Report Number: 1920898-2023-00558
• Device Sequence Number: 6939903
• Product Code: FMF
• UDI-Device Identifier: 00311917048130
• UDI-Public: (01)00311917048130
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• 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,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 928856
• Device Lot Number: 1242591
• 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: 08/01/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• 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