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

Model Number	928857
Medical Device Problem Codes	Leak/Splash (1354); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.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.Investigation conclusion: a complaint lot history check was performed on lot # 0118327 for incorrect placement (stopper is not lined up correctly).This is the 1st related complaint for incorrect placement (stopper is not lined up correctly) on lot # 0118327.A complaint lot history check was performed on lot # 0118327 for difficult/unable to operate (not drawing).This is the 1st related complaint for difficult/unable to operate (not drawing) on lot # 0118327.A review of the device history record was completed for batch# 0118327.All inspections and challenges were performed per the applicable operations qc specifications.There were four (4) notifications [(b)(4)] noted that did not pertain to the complaint.As no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customers indicated failure as no samples or photos were returned.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
Event or Problem Description
It was reported that syringe 0.5ml 31ga 8mm experienced a case of stopper deformation, and being unable or difficult to aspirate.The following information was provided by the initial reporter: material no: 928857 batch no: 0118327.Consumer stated, stopper is not lined up correctly in barrel.Consumer had difficulty communicating what the issue was, stating she suffers from different health problems unrelated to issue she is reporting.Stated, she cannot draw insulin date of event: unknown.

• Brand Name: 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: 11882317
• Report Number: 1920898-2021-00596
• Device Sequence Number: 3685735
• Product Code: FMF
• UDI-Device Identifier: 00311917025360
• UDI-Public: 00311917025360
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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: Other
• Device Expiration Date: 05/31/2025
• Device Model Number: 928857
• Device Catalogue Number: 928857
• Device Lot Number: 0118327
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1