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

Catalog Number 731565

Device Problems Component Missing (2306); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

Device was not accessible for testing.Production records supplied in lieu of physical testing of affected device.

Event Description

End-user has a syringe that won't draw insulin, and a syringe that does not have a rubber gasket.

• Brand Name: MEMBER'S MARK
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield, oh
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield, oh
• Manufacturer Contact: troy smith ; 8695 seward road; fairfield, oh
• MDR Report Key: 9960032
• MDR Text Key: 190775815
• Report Number: 3005798905-2020-02927
• 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: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• 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: 47166
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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