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

Catalog Number 830165

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 05/19/2023

Event Type  malfunction  

Event Description

End user reports that insulin syringe item 830165 lot 53875 plunger has a small orange substance adhered to it.Photographs were provided of the one syringe.

Manufacturer Narrative

Initial trend analysis for lot 53875 was conducted, no malfunctions were found.This is the only complaint for lot 53875.Although the rarity of the occurence, the raw materials will be investigated further to determine how the raw materials embedded in the plunger after injection molding.

Event Description

End user reports that insulin syringe item 830165 lot 53875 plunger has a small orange substance adhered to it.Photographs were provided of the one syringe.

Manufacturer Narrative

The orange substance embedded on the plunger is a result of the plastic particles used in the injection molding process.When the plastic particles are melted at high temperatures during the molding process for the orange cap or handle, some of the orange material becomes embedded into the plunger instead of dissolving at the high temperature, a very rare occurrence.Since the manufacturing of this lot 53875 in 2021, there have already been measures added such as a filter screen to the feeding tube where the plastic particles are added to prevent such plastic impurities from entering the feeding system in march 2023.

• 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: 17074757
• MDR Text Key: 316715996
• Report Number: 3005798905-2023-03118
• 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: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 830165
• Device Lot Number: 53875
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2023
• 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