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 Filling Problem (1233); Off-Label Use (1494)

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

Event Type  malfunction  

Event Description

Pet owner reported, plunger rods are difficult to move.Stated, she will start to give her pet the injection but has to stop because the plunger is hard to push.Stated, she then removes the needle from the injection site to loosen the rod and once its loose enough, she will re-stick the pet to complete dispensing the insulin.Stated, she's experienced this problem for a year with different boxes and asked has the product been changed.Consumer is only reporting one lot number, one box today.Lot: 3198292 catalog: 328521 date of event: unknown samples: yes cl.

Manufacturer Narrative

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.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• 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 CO.; 1 becton drive; franklin lakes, NJ 07417
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 18710462
• MDR Text Key: 335463418
• Report Number: 1920898-2024-05029
• Device Sequence Number: 1
• Product Code: FMF
• 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
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1