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	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 8 syringe 0.3ml 31ga 8mm 10bag 500 pl/wg separated from the hub during use.The following was reported by the initial reporter: "it was reported 8 syringes removed shield and needle hub stayed within the shield.Verbatim: consumer reported found 8 syringes removed shield and needle hub stayed within the shield".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/28/2020.H.6.Investigation: customer returned (3) 3/10cc, 8mm, 31g walgreens syringes in an open poly bag from lot # 0006883.Customer states that the needle hub stayed within the shield.All returned syringes were examined and 2 out of 3 samples were returned with the hub-needle/shield assembly separated from the barrel.A review of the device history record was completed for batch # 0006883 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause: root cause for this defect cannot be determined.Capa#1630423 was initiated.
Event or Problem Description
It was reported that 8 syringe 0.3ml 31ga 8mm 10bag 500 pl/wg separated from the hub during use.The following was reported by the initial reporter: "it was reported 8 syringes removed shield and needle hub stayed within the shield.Verbatim: consumer reported found 8 syringes removed shield and needle hub stayed within the shield.".

• 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: 11103533
• Report Number: 1920898-2020-01790
• Device Sequence Number: 1115157
• Product Code: FMF
• UDI-Device Identifier: 00311917048154
• UDI-Public: 00311917048154
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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: 01/31/2025
• Device Model Number: 928858
• Device Catalogue Number: 928858
• Device Lot Number: 0006883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 01/01/2021
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1