MAUDE Adverse Event Report: MHC MEDICAL PRODCUTS, LLC. MEMBER'S MARK; 731365

Catalog Number 731365

Device Problems Component Missing (2306); Material Twisted/Bent (2981)

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

Event Date 12/20/2018

Event Type  malfunction  

Event Description

Syringes missing caps and have bent needles.

• Brand Name: MEMBER'S MARK
• Type of Device: 731365
• 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: 8391243
• MDR Text Key: 137851953
• Report Number: 3005798905-2018-02801
• 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: Repair
• Type of Report: Initial
• Report Date: 01/07/2019

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: Health Professional
• Device Catalogue Number: 731365
• Device Lot Number: 47945
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 03/05/2019
• 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