MAUDE Adverse Event Report: BERPU MEDICAL TECHNOLOGY CO., LTD EASYTOUCH; SYRINGE

Catalog Number 828155

Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problem Bruise/Contusion (1754)

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

Initial trend analysis for lot 56301 was conducted, no malfunctions were found.This is the only complaint for lot 56301.Cause of complaint was traced to unintended use of device.

Event Description

A representative of the aids project needle exchange program in vermont contacted mhc regarding 2 boxes of syringes that were causing a user bruising, swelling, and burning in injection spots.The syringes are being injected into the user's forearms near the wrist, upper arms near elbow and legs near the knee.Photos are provided of these locations.Upon discussion with the representative of the harm reduction manager, it was disclosed that the syringes are being used for unintended use.

Manufacturer Narrative

No device was returned for testing.Based on the reserved lot investigation of the needle tip integrity testing for lot 56301, no abnormalities were found.

Event Description

A representative of the aids project needle exchange program in vermont contacted mhc regarding 2 boxes of syringes that were causing a user bruising, swelling, and burning in injection spots.The syringes are being injected into the user's forearms near the wrist, upper arms near elbow and legs near the knee.Photos are provided of these locations.Upon discussion with the representative of the harm reduction manager, it was disclosed that the syringes are being used for unintended use.

• Brand Name: EASYTOUCH
• Type of Device: SYRINGE
• Manufacturer (Section D): BERPU MEDICAL TECHNOLOGY CO., LTD; no.14 xingji road; yongxing street; wenzhou city, longwan 32500 0; CH 325000
• Manufacturer (Section G): BERPU MEDICAL TECHNOLOGY CO., LTD; no.14 xingji road; yongxing street; wenzhou city, longwan 32500 0; CH 325000
• Manufacturer Contact: troy smith ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 16682606
• MDR Text Key: 312937489
• Report Number: 3005798905-2023-03109
• 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: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 828155
• Device Lot Number: 56301
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2023
• 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