MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928857
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.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 2 syringe 0.5ml 31ga 8mm 10bag 500 pl/wg experienced hub separation from the device during use.The following information was provided by the initial reporter: material no: 928857, batch no: 9168527.Verbatim: consumer reported needle hub will remove with shield removal found 2 syringes within this box.Lot #: 9168527a, catalog#: 928857, date of event: unknown.
Event or Problem Description
It was reported that 2 syringe 0.5ml 31ga 8mm 10bag 500 pl/wg experienced hub separation from the device during use.The following information was provided by the initial reporter: material no: 928857 batch no: 9168527.Verbatim: consumer reported needle hub will remove with shield removal found 2 syringes within this box lot #: 9168527a catalog#: 928857 date of event: unknown.
Additional Manufacturer Narrative
Investigation: customer returned (44) 1/2cc, 8mm, 31g walgreens syringes (14 loose, 30 in sealed poly bags) with the shelf carton from lot # 9168527.Customer states that the needle hub will remove with shield removal.All returned syringes were tested and no hub-needle assembly separated from the barrel when removing the shield.A review of the device history record was completed for batch# 9168527.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9825930
• Report Number: 1920898-2020-00240
• Device Sequence Number: 754253
• Product Code: FMF
• UDI-Device Identifier: 00311917025360
• UDI-Public: 00311917025360
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2024
• Device Model Number: 928857
• Device Catalogue Number: 928857
• Device Lot Number: 9168527
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other