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

Catalog Number 831165

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 09/14/2023

Event Type  malfunction  

Manufacturer Narrative

End user was notified on the correct and safe method to discard of used syringes.The proper method to discard of used needles is located on the product packaging, no product or labeling malfunction.No capa reported due to instructions provided on product packaging.

Event Description

End user reported that while re-capping syringe 831165 lot 60242 the needle punctured the needle cap and went through the cap which stuck the user's finger.User was advised not to re-cap syringes after use and given alternative methods of discarding the used syringes.

Event Description

End user reported that while re-capping syringe 831165 lot 60242 the needle punctured the needle cap and went through the cap which stuck the user's finger.User was advised not to re-cap syringes after use and given alternative methods of discarding the used syringes.

Manufacturer Narrative

End user was notified on the correct and safe method to discard of used syringes.The proper method to discard of used needles is located on the product packaging, no product or labeling malfunction.Capa was issued as a preventative measure and it is determined at this time that preventative instructions are in place to prevent needle sticks by advising end users to immediately dispose of syringes after use.

• 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: 17809267
• MDR Text Key: 324160004
• Report Number: 3005798905-2023-03137
• 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,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• 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: 60242
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2023
• 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