MAUDE Adverse Event Report: BEAVER VISITEC INTERNATIONAL LIMITED CUSTOMEYES; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Model Number 590307

Device Problem Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Event Description

There are lots of white plastic bits within the chamber of the syringe.

• Brand Name: CUSTOMEYES
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): BEAVER VISITEC INTERNATIONAL LIMITED; waterloo industrial estate; bidford-on-avon, B50 4 JH; UK B50 4JH
• Manufacturer (Section G): BEAVER-VISITEC INTERNATIONAL, LTD; waterloo industrial estate; bidford on avon, warwickshire B50 4 JH; UK B50 4JH
• Manufacturer Contact: martin peeke ; waterloo industrial estate; bidford-on-avon, B50 4-JH ; UK B50 4JH
• MDR Report Key: 12046954
• MDR Text Key: 260692436
• Report Number: 3002808441-2021-00003
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/16/2021
• Device Model Number: 590307
• Device Lot Number: 3270402
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 06/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1