MAUDE Adverse Event Report: MHC MEDICAL PRODCUTS, LLC. N/A; INSULIN SYRINGE

Catalog Number N/A

Device Problems Device Difficult to Setup or Prepare (1487); Dull, Blunt (2407)

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

Event Date 01/02/2019

Event Type  malfunction  

Event Description

Hard to draw insulin.Needles feel dull.Customer did not provide any product information, i.E., lot number, item number, etc.

• Brand Name: N/A
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODCUTS, LLC.; 8695 seward road; fairfield OH 45011
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• Manufacturer Contact: jennifer seiple ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 8391220
• MDR Text Key: 137851921
• Report Number: 3005798905-2018-02797
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• 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: Lay User/Patient
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/02/2018
• Initial Date FDA Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: No
• 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