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

Device Problems Product Quality Problem (1506); Device Misassembled During Manufacturing /Shipping (2912); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2023

Event Type  malfunction  

Manufacturer Narrative

Initial trend analysis for lots 50273 and 54487 was conducted, no malfunctions were found.This is the only complaint for lots 50273 and 54487.Further investigation will be conducted to determine the root cause of complaint.

Event Description

End user reports that several boxes of items 829155 lot 50273 and item 830355 lot 54487 that the cannulas are shorter in length and "cut in half".Both syringes are 1/2" in size.

Event Description

End user reports that several boxes of items 829155 lot 50273 and item 830355 lot 54487 that the cannulas are shorter in length and "cut in half".Both syringes are 1/2" in size.

Manufacturer Narrative

Initial trend analysis for lots 50273 and 54487 was conducted, no malfunctions were found.No abnormalities found during retained lot testing.

• 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: 18238477
• MDR Text Key: 329382266
• Report Number: 3005798905-2023-03150
• 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: 11/21/2023

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 11/17/2023
• Supplement Dates FDA Received: 01/15/2024
• 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