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

Catalog Number 830155

Device Problems Product Quality Problem (1506); Material Integrity Problem (2978); Material Too Soft/Flexible (4007)

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

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

Retained lot numbers 53595 and 53443 were investigated.A cannula toughness test detected no malfunction in either lots.During the manufacturing process all syringes are assembled by a machine with an image equipped with image detection system which removes bent needles during the manufacturing process.These two tests show no indication of abnormalities or malfunctions during time of production.According to the investigations provided the cause is likely due to the user's improper operation the syringes.

Event Description

End user reports cannulas on the syringes are bending and deplugging from lot 53595 exp 03/05/2026 and lot 53443 exp 001/07/2026.User reports that twice the deplugging has resulted in the cannula breaking off and becoming stuck in her abdomen however, the cannula is easily retrieved with tweezers.

• Brand Name: EASYTOUCH
• 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: 12758872
• MDR Text Key: 281743726
• Report Number: 3005798905-2021-03021
• 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: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 830155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Date Manufacturer Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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