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

Model Number	328291
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's address is unknown.New jersey, usa, usa has been used as a default.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 5 bd insulin syringes with the bd ultra-fine¿ needle had difficult plunger movement during use.The following information was provided by the initial reporter: "medical research lab injecting mice asking for information on 328291 plunger hard to move lab tech reported using the syringes to inject his mice for a study.Finding the plunger harder to move in this box than a prior box of the bd insulin syringes on 5 syringes.".
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# 2199411.All inspections and challenges were performed per the applicable operations qc specification.H3 other text : see h10.
Event or Problem Description
It was reported that 5 bd insulin syringes with the bd ultra-fine¿ needle had difficult plunger movement during use.The following information was provided by the initial reporter: "medical research lab injecting mice asking for information on 328291 plunger hard to move lab tech reported using the syringes to inject his mice for a study.Finding the plunger harder to move in this box than a prior box of the bd insulin syringes on 5 syringes".

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15947662
• Report Number: 1920898-2022-00862
• Device Sequence Number: 20425901
• Product Code: FMF
• UDI-Device Identifier: 50382903282918
• UDI-Public: 00382903282913
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2022

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: Health Professional
• Device Model Number: 328291
• Device Catalogue Number: 328291
• Device Lot Number: 2199411
• 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: 11/16/2022
• Supplement Date Received by Manufacturer: 12/30/2022
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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