MAUDE Adverse Event Report: COVIDIEN DOVER; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER

Model Number 8887603085

Device Problem Deflation Problem (1149)

Patient Problem No Patient Involvement (2645)

Event Date 10/27/2018

Event Type  malfunction  

Manufacturer Narrative

Date submitted: november 6, 2018 the complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states when pretesting the balloon before catheter insertion, the staff member had to discard two catheters after the balloon was inflated with the full volume of fluid, but could not be deflated.

• Brand Name: DOVER
• Type of Device: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER
• Manufacturer (Section D): COVIDIEN; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer (Section G): COVIDIEN; boulevard insurgentes 19030; tijuana 22225 ; MX 22225
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 8042075
• MDR Text Key: 126520981
• Report Number: 2024500-2018-00001
• Device Sequence Number: 1
• Product Code: FCM
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8887603085
• Device Catalogue Number: 8887603085
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2018
• 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