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

Catalog Number 731365

Device Problems Device Difficult to Setup or Prepare (1487); Free or Unrestricted Flow (2945)

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

Event Date 01/28/2021

Event Type  malfunction  

Event Description

End-user reported that the syringes are not drawing insulin and that "the insulin is flowing right out of the syringe.".

• Brand Name: MEMBER'S MARK
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• Manufacturer Contact: kristin peters ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 11429602
• MDR Text Key: 242931414
• Report Number: 3005798905-2021-02981
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 731365
• Device Lot Number: 51296
• Date Manufacturer Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: No
• 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