MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928858
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0006883, medical device expiration date: 2025-01-31, device manufacture date: 2020-01-06.Medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe 0.3ml 31ga 8mm 10bag 500 pl/wg needle hub separated.The following information was provided by the initial reporter: material no:928858 batch no: 0006883, unknown.It was reported that the shields are hard to remove and the needle hub stays in the shield.
Event or Problem Description
It was reported that syringe 0.3ml 31ga 8mm 10bag 500 pl/wg needle hub separated.The following information was provided by the initial reporter: material no:928858, batch no: 0006883, unknown.It was reported that the shields are hard to remove and the needle hub stays in the shield.
Additional Manufacturer Narrative
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 device history record was completed for batch# 0006883.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.

• Brand Name: SYRINGE 0.3ML 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: 11096140
• Report Number: 1920898-2020-01774
• Device Sequence Number: 10974587
• Product Code: FMF
• UDI-Device Identifier: 00311917048154
• UDI-Public: 00311917048154
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/12/2021

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: Lay User/Patient
• Device Model Number: 928858
• Device Catalogue Number: 928858
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1