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

Catalog Number 730565

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/16/2019

Event Type  malfunction  

Event Description

Needle detached in end-user's skin.

Manufacturer Narrative

No device was returned for testing.In lieu of testing the associated lot, production reports have been provided.Upon analyzing the production reports, no malfunctions were detected.

Event Description

Needle detached in end-user's skin.

• Brand Name: MEMBER'S MARK
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC.; 8695 seward rd.; fairfield, oh OH 45011
• MDR Report Key: 9590904
• MDR Text Key: 175039330
• Report Number: 3005798905-2020-02898
• 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: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 730565
• Device Lot Number: 55023
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1