MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH; INSULIN SYRINGE

Catalog Number 829155

Device Problems Product Quality Problem (1506); Dull, Blunt (2407)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2020

Event Type  malfunction  

Event Description

End-user called in and reported that they are experiencing syringes with barbed needles.

Event Description

End-user called in and reported that they are experiencing syringes with barbed needles.

Manufacturer Narrative

Retained lot testing was conducted by manufacturer.Puncture force testing showed no signs of deviation or abnormality when testing retained samples.Production records were also analyzed adn no abnormalities or deviations were found.At this time there are no abnormalities detected.

• Brand Name: EASYTOUCH
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• MDR Report Key: 10434521
• MDR Text Key: 204270626
• Report Number: 3005798905-2020-02963
• 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: 08/07/2020

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: 829155
• Device Lot Number: 51154
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 08/20/2020
• Supplement Dates Manufacturer Received: 07/02/2020
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1