MAUDE Adverse Event Report: MHC MEDICAL PRODCUTS, LLC. MVP; INSULIN SYRINGE

Catalog Number 819550

Device Problems Fluid/Blood Leak (1250); Device Difficult to Setup or Prepare (1487); Device Dislodged or Dislocated (2923)

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

Event Date 12/14/2018

Event Type  malfunction  

Event Description

Syringes are not drawing up insulin, plunger is difficult to draw back, and needles dislodges from barrel.

• Brand Name: MVP
• 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: 8391234
• MDR Text Key: 137851956
• Report Number: 3005798905-2018-02800
• 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: 01/07/2019

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: 819550
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2018
• 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