MAUDE Adverse Event Report: BEAVER VISITEC WALTHAM MASS VISITEC CANNULA ANTERIOR CHAMBER 30 GAGE (10 PER PACK)

Catalog Number 581273

Device Problems Disconnection (1171); Product Quality Problem (1506); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problems Hemorrhage/Bleeding (1888); Vitreous Loss (2142); Rupture (2208)

Event Date 09/30/2015

Event Type  Injury  

Manufacturer Narrative

This or similar issues have been reported to bvi in the past and in all cases it has been determined through exhaustive testing and investigation of product that the cannula can only detach from the luer-lok system as a projectile or otherwise if the user fails to fully engage the luer-lok such that the connection is not made properly allowing the cannula to disengage during use.In this case, the user was not able to provide the specific device used to bvi for full evaluation and no specific issues were reported.Thus we are unable to determine if any product issues may have contributed to the event.

Event Description

( verbatim from report): "- received a fax from the ansm on behalf of the customer stating a quality problem with the cannulas (b)(4).The cannula disconnected itself from the luer-lock syringe thus being projected into the patient 's eye.Clinical consequences are as follows: a capsula rupture , vitreous loss , dislocation of the implant, significant intravitreal hemorrhaging." the product in this is not being returned for investigation by the end user who stated it is not available.Therefore, beaver visitec is unable to determine if any issues specific to the device is in question that contributed to the incident.However, we have had reports of similar incidents and through multiple exhaustive investigations have found that these issues to date were the result of user error and were not attributed to any product defects or deficiencies.Please refer to attached investigation reports.

• Brand Name: VISITEC CANNULA ANTERIOR CHAMBER 30 GAGE (10 PER PACK)
• Type of Device: CANNULA
• Manufacturer (Section D): BEAVER VISITEC WALTHAM MASS; 411 waverly oaks rd; waltham MA 02452
• Manufacturer (Section G): BEAVER VISITEC; 411 waverly oaks rd; waltham MA 02452
• Manufacturer Contact: jean mattar ; 411 waverly oaks rd; waltham, MA 02452 ; 7819067916
• MDR Report Key: 5332219
• MDR Text Key: 34584618
• Report Number: 1211998-2015-00002
• Device Sequence Number: 1
• Product Code: HMX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 581273
• Device Lot Number: 3128499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/03/2015
• Date Manufacturer Received: 10/03/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention