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

Catalog Number 830555

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975); Inadequate Lubrication (4057)

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

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

Initial trend analysis for lots 60717, 58185, 57076, 57065 was conducted, no malfunctions were found.This is the only complaint for lot 60717, 58185, 57076, 57065.Further investigation will be conducted to determine the root cause of complaint.

Event Description

End user reports discrepancies between the different facilities that manufacture the easytouch syringes.The user reports that lots 60717 exp date 04/02/2028, lot 58185 exp date 01/21/2027, lot 57076 exp date 10/29/2026 and lot 57065 exp 11/15/2026 appear to have different coloring on the polybags, the finger grips are larger, the syringe barrels are bowed and the scarcity of lubrication in the syringe barrel makes it difficult to administer the full amount of insulin.

• 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: 17600374
• MDR Text Key: 321742541
• Report Number: 3005798905-2023-03132
• 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: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 830555
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2023
• 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