MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928856
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9217849, medical device expiration date: 2024-08-31, device manufacture date: 2019-08-05, medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.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 an unspecified number of syringes 1.0ml 31ga 8mm 10bag 500 pl/wg experienced an inability or difficulty to aspirate.Product defect was noted during use.The following information was provided by the initial reporter: material no.928856 batch no.9217849, unknown.Verbatim: distributor consumer reported that she is not able to draw insulin with syringes.Stated, all syringes she attempted to use so far are not working, (count unknown) stated, she purchased two boxes and both boxes had issue.Lot: 9217849, catalog: 928856, date of event: unknown, samples available.Lot: unknown, catalog: 928856, date of event: unknown.
Additional Manufacturer Narrative
Investigation: customer returned (10) 1cc, 8mm, 31g walgreens syringes in an open poly bag from lot # 9217849.Customer states that syringes are not drawing up insulin.All returned syringes were tested and all were able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 9217849.All inspections 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.
Event or Problem Description
It was reported that an unspecified number of syringes 1.0ml 31ga 8mm 10bag 500 pl/wg experienced an inability or difficulty to aspirate.Product defect was noted during use.The following information was provided by the initial reporter: material no.928856 batch no.9217849, unknown.Verbatim: distributor consumer reported that she is not able to draw insulin with syringes.Stated, all syringes she attempted to use so far are not working, (count unknown) stated, she purchased two boxes and both boxes had issue lot: 9217849 catalog: 928856 date of event: unknown samples available.Lot: unknown catalog: 928856 date of event: unknown.

• Brand Name: SYRINGE 1.0ML 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
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9826504
• Report Number: 1920898-2020-00241
• Device Sequence Number: 19021154
• Product Code: FMF
• UDI-Device Identifier: 00311917048130
• UDI-Public: 00311917048130
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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 Model Number: 928856
• Device Catalogue Number: 928856
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 03/17/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown