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

Device Problems Product Quality Problem (1506); Dull, Blunt (2407)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

Initial trend analysis for lot 57162 and 56312 was conducted, no malfunctions were found.This is the only complaint for lot 57162 and 56312.Further investigation will be conducted to determine the root cause of complaint.

Event Description

End user reports while using insulin syringes 828155 lot 56312, and item 830165 lot 57162 that the cannulas are bent, crooked and not centered in the base of the syringe hub.Due to this, the end user reports that the cannula are challenging to enter into the skin tissue and causing injury but would not elaborate on that.Previous report by end user documents that the user is using the syringes with fentanyl and injecting near the elbow, wrist and back/front of knee cap.

• Brand Name: EASYTOUCH
• Type of Device: INSULIN 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: 17166854
• MDR Text Key: 318024175
• Report Number: 3005798905-2023-03122
• 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: Notification
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2023
• 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