MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC MEMBER'S MARK; INSULIN SYRINGE

Catalog Number 731165

Device Problems Unstable (1667); Unintended Movement (3026)

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

Event Date 02/18/2021

Event Type  malfunction  

Event Description

End-user experienced loose insulin syringe plunger.The loose plunger did not provide a vacuum strong enough for the user to draw their insulin.

Event Description

End-user experienced loose insulin syringe plunger.The loose plunger did not provide a vaccuum strong enough for the user to draw their insulin.

Manufacturer Narrative

No device was returned for testing.Retained lot # 51294 was investigated.Plunger slide performace testing showed no indicator of abnormality/malfunction.Production records were analyzed.No abnormality/malfunction was found at time of production.

• Brand Name: MEMBER'S MARK
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• MDR Report Key: 11519600
• MDR Text Key: 241454914
• Report Number: 3005798905-2021-02986
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K102178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 731165
• Device Lot Number: 51294
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1