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

Catalog Number	328421
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd ultra-fine¿ insulin syringe there was foreign matter found.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: aspirating medicine with a ready-to-use sterile syringe on the operating table, after removing the needle cap, the sterile needle is found wrapped in plastic.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary no samples or 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# 1012907.All inspections were performed per the applicable operations qc specification.There were zero (0) notifications noted that did not pertain to the complaint.
Event or Problem Description
It was reported while using bd ultra-fine¿ insulin syringe there was foreign matter found.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: aspirating medicine with a ready-to-use sterile syringe on the operating table, after removing the needle cap, the sterile needle is found wrapped in plastic.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16211189
• Report Number: 1920898-2023-00011
• Device Sequence Number: 12108208
• Product Code: FMF
• UDI-Device Identifier: 00382903052721
• UDI-Public: (01)00382903052721
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 328421
• Device Lot Number: 1012907
• 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: 12/30/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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