MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE; PISTON SYRINGE

Model Number 328438

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Investigation summary: samples were received and an investigation was performed.This is the 13th complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Bd was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Corrective/preventative action (capa) has been initiated.Investigation conclusion: a complaint history check was performed and this is the 13th related complaint for needle hub separates on lot # 0125308.Manufacturing (holdrege) will be notified of the observed issue.A review of the device history record was completed for batch# 0125308.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200893682] noted for out of spec shield pull.Based on the samples and/or photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that 9 bd insulin syringe with bd ultra-fine¿ needles experienced hub separation from the device.The following information was provided by the initial reporter: consumer reported when removing orange needle shield needle hub detaches from syringe.Consumer stated 9 syringes have been affected.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12652053
• MDR Text Key: 280953312
• Report Number: 1920898-2021-01087
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908438032
• UDI-Public: 00382908438032
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial
• Report Date: 09/21/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 328438
• Device Catalogue Number: 328438
• Device Lot Number: 0125308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1