MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.5ML 31GA 8MM; PISTON SYRINGE

Model Number	329408
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: a complaint history check was performed and this is the 1st related complaint for needle hub separates on lot # 9343440.A review of risk management (b)(4) revision 13 indicates that the potential risk of this specific reported incident (syringe, needle hub separates) was captured and addressed.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# 9343440.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification (b)(4) noted that did not pertain to the complaint.There was one (1) notification (b)(4) noted for cracked hubs.As no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that during use the hub separated from device and remained in cap with a bd syringe 0.5ml 31ga 8mm.The following information was provided by the initial reporter: it was reported that when the consumer removed the orange cap from several syringes, the whole needle component separates with it.
Event or Problem Description
It was reported that the hub separated from device and remained in cap with bd syringe 0.5ml 31ga 8mm.This occurred on 7 separate occasions, however, the date/time information is unknown.The following information was provided by the initial reporter: it was reported that when the consumer removed the orange cap from several syringes, the whole needle component separates with it.
Additional Manufacturer Narrative
The following field has been updated with additional information (number of occurrences): b.5.Describe event or problem: it was reported that the hub separated from device and remained in cap with bd syringe 0.5ml 31ga 8mm.This occurred on 7 separate occasions, however, the date/time information is unknown.The following information was provided by the initial reporter: it was reported that when the consumer removed the orange cap from several syringes, the whole needle component separates with it.

• Brand Name: BD SYRINGE 0.5ML 31GA 8MM
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10371184
• Report Number: 1920898-2020-01004
• Device Sequence Number: 11529554
• Product Code: FMF
• UDI-Device Identifier: 00382903294084
• UDI-Public: 00382903294084
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2024
• Device Model Number: 329408
• Device Catalogue Number: 329408
• Device Lot Number: 9343440
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other