MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE WITH PERMANENTLY ATTACHED BD SAFETYGLIDE SAFETY NEEDLE; PISTON SYRINGE

Model Number	305945
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fda notified?: the initial reporter also notified the fda on 2020-06-24 via medwatch # (b)(4).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# 9269165.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Occurrence: a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of safety mechanism broke (safetyglide) with lot #9269165 regarding item #305945.Investigation conclusion: 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 above, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that the safety mechanism on the bd¿ syringe with permanently attached bd safetyglide¿ safety needle failed and "flew off" when engaged after use.The following information was provided by the initial reporter: "when the safety was engaged on the bd safetyglide 1ml syringe, the safety flew off and didn't cap needle.Very big potential for needle stick.What was the original intended procedure? numbing for iv.What problem did the user have: device failed.".

• Brand Name: BD SYRINGE WITH PERMANENTLY ATTACHED BD SAFETYGLIDE SAFETY NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10624094
• Report Number: 1920898-2020-01349
• Device Sequence Number: 3054504
• Product Code: MEG
• UDI-Device Identifier: 30382903059455
• UDI-Public: 30382903059455
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2020

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: Other
• Device Expiration Date: 09/30/2024
• Device Model Number: 305945
• Device Catalogue Number: 305945
• Device Lot Number: 9269165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 10/02/2020
• 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