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

Catalog Number 731565

Device Problems Fluid/Blood Leak (1250); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2019

Event Type  malfunction  

Event Description

Plunger in the syringes are pushing insulin out.

Event Description

Plunger in the syringes are pushing insulin out.

• Brand Name: MEMBER'S MARK
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC.; 8695 seward rd.; fairfield OH 45011
• MDR Report Key: 9242369
• MDR Text Key: 163956542
• Report Number: 3005798905-2019-02879
• 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: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 731565
• Device Lot Number: 45324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1