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

Catalog Number 731565

Device Problems Nonstandard Device (1420); Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/02/2019

Event Type  malfunction  

Event Description

Air is getting into syringe barrel when drawing up insulin.The gasket doesn't seem to be sealed and creating a proper vacuum for the insulin to be drawn.

• Brand Name: MEMBER'S MARK
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODCUTS, LLC.; 8695 seward road; fairfield OH 45011
• Manufacturer (Section G): MHC MEDICAL PRODCUTS, LLC.; 8695 seward road; fairfield OH 45011
• Manufacturer Contact: jennifer seiple ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 8391224
• MDR Text Key: 137851793
• Report Number: 3005798905-2018-02806
• 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
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• 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?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1