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	11/30/2020
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 7 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 that needle hub separated when removing shield.Verbatim: from phone call on 2020-11-30 17:21:40:.Lot: 9324122.Catalog: 928858.Date of event: unknown.Samples: yes cl.From phone call on 2020-11-30 17:19:04: consumer stated, needle hub separated when removing shield.7 syringes affected cl.Received voicemail from walgreens consumer stating, 7 syringes did not work.Returned call cl".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-01-11.H6: investigation summary: customer returned (8) used 0.3ml insulin syringes from lot 9324122.Consumer stated needle hub separated when removing shield.All 8 returned syringes were examined, and all 8 exhibited separated needle hub/shield assemblies; no damage to the barrel tips was observed.A review of the device history record was completed for batch # 9324122 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [200865195] noted that did not pertain to the complaint.Bd was able to confirm the customer¿s indicated failure hub separated when removing shield.Root cause for this defect cannot be determined.Capa1630423 has been opened to address this issue.
Event or Problem Description
It was reported that 7 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 that needle hub separated when removing shield.Verbatim: from phone call on 2020-11-30 17:21:40:.Lot: 9324122; catalog: 928858, date of event: unknown, samples: yes cl.From phone call on 2020-11-30 17:19:04: consumer stated, needle hub separated when removing shield.7 syringes affected cl.Received voicemail from walgreens consumer stating, 7 syringes did not work.Returned call cl".

• 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: 11083473
• Report Number: 1920898-2020-01762
• Device Sequence Number: 14126924
• Product Code: FMF
• UDI-Device Identifier: 00311917048154
• UDI-Public: 00311917048154
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 02/05/2021

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: 12/31/2024
• Device Model Number: 928858
• Device Catalogue Number: 928858
• Device Lot Number: 9324122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1