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

Catalog Number 731365

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  malfunction  

Event Description

Syringe is releasing insulin before the user is ready to inject.

• Brand Name: MEMBER'S MARK
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC.; 8695 seward rd.; fairfield OH 45011
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC.; 8695 seward rd.; fairfield OH 45011
• Manufacturer Contact: jennifer seiple ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 9242376
• MDR Text Key: 163957054
• Report Number: 3005798905-2019-02855
• 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: 09/06/2019

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: No Information
• Device Catalogue Number: 731365
• Device Lot Number: 45354
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/25/2019
• 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