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

Catalog Number 830165

Device Problems Off-Label Use (1494); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

A nurse practitioner noticed that the insulin syringes are leaking fluid and the plunger provides weak suction during use.Due to the syringes being used for unintended use as indicated by the reporter, the syringes are not malfunctioning.

Manufacturer Narrative

Production records investigated for lot number 60154.The testing showed no indication of abnormalities or malfunction at time of production.

Manufacturer Narrative

Production records investigated for lot number 60154.No abnormalities found during retained lot testing.

Event Description

A nurse practitioner noticed that the insulin syringes are leaking fluid and the plunger provides weak suction during use.Due to the syringes being used for unintended use as indicated by the reporter, the syringes are not malfunctioning.

• 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: 18276609
• MDR Text Key: 330818841
• Report Number: 3005798905-2023-03152
• 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: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 830165
• Device Lot Number: 60154
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2023
• 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