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

Catalog Number 831165

Device Problems Product Quality Problem (1506); Dull, Blunt (2407); Infusion or Flow Problem (2964); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Pain (1994)

Event Date 12/21/2023

Event Type  malfunction  

Manufacturer Narrative

Production records investigated for lot number 59272.The testing showed no indication of abnormalities or malfunction at time of production.

Event Description

End user reports that syringes from lot 59272 are partially clogging while using lantus and apidra insulin.User reports that the cannulas are causing more pain and bruising as well.

Event Description

End user reports that syringes from lot 59272 are partially clogging while using lantus and apidra insulin.User reports that the cannulas are causing more pain and bruising as well.

Manufacturer Narrative

Based upon the retained lot testing, no abnormalities found for syringe lot 59272.

• Brand Name: EASYTOUCH
• Type of Device: SYRINGES
• 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: 18387872
• MDR Text Key: 331488017
• Report Number: 3005798905-2023-03157
• 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: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 831165
• Device Lot Number: 59272
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/21/2023
• 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