MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE WALGREENS THIN INSULIN SYRINGES 1.0ML 31GAUGE 5/16"; PISTON SYRINGE

Catalog Number	928856
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using walgreens thin insulin syringes 1.0ml 31gauge 5/16" the needle did not properly aspirate the medication.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported finding needles with burrs from this box.Consumer reported finding syringes that would not draw up medication.
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.H6: investigation summary a complaint lot history check was performed on lot # 3065277 for difficult/unable to operate - not drawing.This is the 1st related complaint for difficult/unable to operate - not drawing on lot # 3065277.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 manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.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.A review of the device history record was completed for batch# 3065277.All inspection performed per the applicable operations qc specification.There was one (1) notification [201079269] noted that did not pertain to the complaint.There was one (1) notification [201079207] noted high sustaining force.As no samples were received the investigation concluded: unconfirmed: embecta was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause cannot be determined at this time as the issue is unconfirmed as no samples were returned.

• Brand Name: WALGREENS THIN INSULIN SYRINGES 1.0ML 31GAUGE 5/16"
• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17778311
• Report Number: 1920898-2023-00635
• Device Sequence Number: 6615371
• Product Code: FMF
• UDI-Device Identifier: 00311917048130
• UDI-Public: (01)00311917048130
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2023

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 Catalogue Number: 928856
• Device Lot Number: 3065277
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2023
• 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