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 Consequences Or Impact To Patient (2199)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 5 syringes 0.5ml 31ga 8mm 10bag 500 pl/wg experienced leakage.The following information was provided by the initial reporter: consumer reported found in one packet 5 syringes with a hole in barrel.Insulin leaked out when drawing.Lot #: 9189631b, catalog#: 928857, date of event: (b)(6) 2020.
Event or Problem Description
It was reported that 5 syringes 0.5ml 31ga 8mm 10bag 500 pl/wg experienced leakage.The following information was provided by the initial reporter: consumer reported found in one packet 5 syringes with a hole in barrel.Insulin leaked out when drawing.Lot#: 9189631b, catalog#: 928857, date of event: on (b)(6) 2020.
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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#: 9189631.All inspections and challenges were performed per the applicable operations qc specifications.There were three (3) notifications noted that did not pertain to the complaint.

• 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: 10920337
• Report Number: 1920898-2020-01647
• Device Sequence Number: 1429478
• Product Code: FMF
• UDI-Device Identifier: 00311917025360
• UDI-Public: 00311917025360
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/28/2021

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 Expiration Date: 07/31/2024
• Device Model Number: 928857
• Device Catalogue Number: 928857
• Device Lot Number: 9189631
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 11/30/2020
• Supplement Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1