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

Catalog Number 830565

Device Problems Restricted Flow rate (1248); Product Quality Problem (1506); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/18/2024

Event Type  malfunction  

Manufacturer Narrative

Initial trend analysis for lot 57025 was conducted, no malfunctions were found.This is the only complaint for lot 57025.Further investigation will be conducted to determine the root cause of complaint.

Event Description

End user reports that syringes 830565 from lot 57025 are clogged.

Manufacturer Narrative

Retained lot samples for syringe lot 57025 was tested for clogged cannulas.No abnormalities were found during testing.

Event Description

End user reports that syringes 830565 from lot 57025 are clogged.

• 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: 19166633
• MDR Text Key: 341670206
• Report Number: 3005798905-2024-03179
• 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: 04/23/2024

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
• Device Catalogue Number: 830565
• Device Lot Number: 57025
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2024
• Initial Date FDA Received: 04/23/2024
• 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