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

Catalog Number 831365

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problems Laceration(s) (1946); Needle Stick/Puncture (2462)

Event Date 03/27/2024

Event Type  Injury  

Manufacturer Narrative

Production records investigated for lot number 63982.The testing showed no indication of abnormalities or malfunction at time of production.

Event Description

The owner of a medical clinic reports that the cannulas in two syringes were protruding through the orange needle cap at a 45 degree angle which resulted in two medical assistants to be stuck by the exposed cannulas on both the thumb and fingers.The assistants stuck themselves while taking the needle cap off prior to drawing up medication.No medical attention was sought out.Those affected was their hands and discarded of the syringes.Another syringe was uncapped from the same polybag and the cannula appeared split, this syringe was discarded and a new box was opened.

Manufacturer Narrative

Capa-23 and (b)(4) closed with the inspection of the newly implemented pe bag packaging process.Data provided with testing of (b)(4) production batches manufactured since the implementation of the new procedure.

Event Description

The owner of a medical clinic reports that the cannulas in two syringes were protruding through the orange needle cap at a 45 degree angle which resulted in two medical assistants to be stuck by the exposed cannulas on both the thumb and fingers.The assistants stuck themselves while taking the needle cap off prior to drawing up medication.No medical attention was sought out.Those affected was their hands and discarded of the syringes.Another syringe was uncapped from the same polybag and the cannula appeared split, this syringe was discarded and a new box was opened.

• 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: 19006827
• MDR Text Key: 338944466
• Report Number: 3005798905-2024-03171
• 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: Physician Assistant
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 831365
• Device Lot Number: 63982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other