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

Catalog Number 731565

Device Problem Mechanical Problem (1384)

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

Event Date 05/06/2019

Event Type  malfunction  

Event Description

Syringe won't pull insulin.

Manufacturer Narrative

Product was not returned by end-user.Manufacturer is unable to test associated lot.Prouduction records have been supplied in lieu of testing the associated lot.Production records have been analyzed and no malfunctions were detected.

Event Description

Syringe won't pull insulin.

• 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: 8820101
• MDR Text Key: 152031615
• Report Number: 3005798905-2019-02848
• 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: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 47986
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 05/06/2019
• Supplement Dates FDA Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1