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	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using walgreens thin insulin syringes 1.0ml 31gauge 5/16" there was difficulty aspirating.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported needles bend during injection.Consumer also reported that the needle will not draw.
Additional Manufacturer Narrative
H6: investigation summary: no samples 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# 3030370.All inspections were performed per the applicable operations qc specification.H3 other text : see h10.
Event or Problem Description
It was reported while using walgreens thin insulin syringes 1.0ml 31gauge 5/16" there was difficulty aspirating.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported needles bend during injection.Consumer also reported that the needle will not draw.

• 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: 17484957
• Report Number: 1920898-2023-00537
• Device Sequence Number: 12574344
• 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,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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: 3030370
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• 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