MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASY TOUCH; SYRINGE

Catalog Number 829555

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Laceration(s) (1946); Needle Stick/Puncture (2462)

Event Date 04/06/2022

Event Type  Injury  

Event Description

End user reports that the cannula is deplugging from the hub into her husband's arm and fatty part of stomach skin from item number 829555 lot# 52621 expiration date 10/3/2025.The end user that is receiving the insulin dose has parkinsons disease so the wife is the adminster of the insulin twice daily and this is the third syringe from this lot# 52621 that the needle has deplugged.The total of three times the wife was able to recover the cannula(s) from the end user's skin.

Manufacturer Narrative

Initial trend analysis and production records investigated for item number 829555 lot# 52621 was conducted, no malfunctions were found.Further investigation will be conducted to determine the root cause of complaint.

Event Description

End user reports that the cannula is deplugging from the hub into her husband's arm and fatty part of stomach skin from item number 829555 lot# 52621 expiration date 10/3/2025.The end user that is receiving the insulin dose has parkinsons disease so the wife is the adminster of the insulin twice daily and this is the third syringe from this lot# 52621 that the needle has deplugged.The total of three times the wife was able to recover the cannula(s) from the end user's skin.

Manufacturer Narrative

Retained lot number 52621 was tested for bond firmness between needle and hub, no abnormalities occured during manufacturing process or during inspection process.Lot 52621 meets iso standards requirements for breakage force and needle and hub connection.No abnormalities were found during reserved lot testing.In the future, during manufacturing the strength of the bond firmness will be changed from 2 times to 3 times during the sampling shift to limit reports.

• Brand Name: EASY TOUCH
• Type of Device: SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• Manufacturer Contact: troy smith ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 14057073
• MDR Text Key: 288906538
• Report Number: 3005798905-2022-03046
• 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,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 829555
• Device Lot Number: 52621
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 04/06/2022
• Supplement Dates FDA Received: 05/07/2022
• 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
• Patient Outcome(s): Other