MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 SYRINGE 0.3ML 31G 6MM S/C U-100 RELION; SYRINGE, PISTON

Model Number 328521

Device Problems Device Markings/Labelling Problem (2911); No Flow (2991)

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

Event Type  malfunction  

Event Description

Consumer reported the scale markings are no consistent on the barrel of syringe.Stated, the lines are not positioned in the correct place.Stated, she did not use the syringe.She noticed the problem a few weeks ago and just today remembered to call in to report it.1 syringe affected.Lot: 3044494.Catalog: 328521.Date of event: unknown.

Manufacturer Narrative

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 0.3ML 31G 6MM S/C U-100 RELION
• 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: 18398211
• MDR Text Key: 331405676
• Report Number: 1920898-2023-05003
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131138383
• UDI-Public: (01)00681131138383
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328521
• Device Lot Number: 3044494
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1