MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL; Syringe, piston

Model Number 328509

Device Problems Leak/Splash (1354); No Flow (2991)

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

Event Type  malfunction  

Event Description

Consumer reported she could not draw her insulin to take injection.Stated, some of the insulin was leaking from the barrel.Stated, it happened last week but could not remember the exact date.1 syringe affected.Lot: 3156431.Catalog: 328509.Date of event: unknown.Sample: yes cl.

Manufacturer Narrative

Correction to h6, device code.Investigation summary: samples were received and an investigation was performed.This is the 1st 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.Embecta 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.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.

• Brand Name: SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL
• Type of Device: Syringe, piston
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes, NJ 07417
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 18570154
• MDR Text Key: 333556453
• Report Number: 1920898-2024-05011
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131311762
• UDI-Public: 00681131311762
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328509
• Device Lot Number: 3156431
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/05/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1