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

Catalog Number 827155

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

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

Event Date 08/24/2023

Event Type  Injury  

Manufacturer Narrative

Production records investigated for lot number 59683.The testing showed no indication of abnormalities or malfunction at time of production.

Event Description

A pharmacist from southlake pharmacy reported that a pharmacy technitian (j.S.) was stuck by an uncapped syringe needle through the polybag.The syringe cap was sealed inside of the polybag but the cannula was exposed resulting in a finger stick on the left index finger.The pharmacy technician did not seek medical attention.Southlake pharmacy dispenses the syringes by polybag based on the prescription given, which causes the pharmacy technitian to handle the polybags.

Manufacturer Narrative

Cmo determined that the root cause could have been during syringe production, after inspecting the retained samples and doing a random check during production, this was considered to be an isolated incident.No abnormalities were found for lot 59683 during inspection.Another check on the needle capping/polybag packing process will be checked again in 3 months.

Event Description

A pharmacist from (b)(6) pharmacy reported that a pharmacy technician ((b)(6)) was stuck by an uncapped syringe needle through the polybag.The syringe cap was sealed inside of the polybag but the cannula was exposed resulting in a finger stick on the left index finger.The pharmacy technician did not seek medical attention.(b)(6) pharmacy dispenses the syringes by polybag based on the prescription given, which causes the pharmacy technician to handle the polybags.

• 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: 17627191
• MDR Text Key: 322018262
• Report Number: 3005798905-2023-03133
• 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: Replace
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 827155
• Device Lot Number: 59683
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 08/24/2023
• Supplement Dates FDA Received: 09/21/2023
• 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
• Patient Outcome(s): Other; Required Intervention