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

Model Number 8887603085

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 7/26/2018.The incident sample has been requested but to date has not been received at the manufacturing site for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.

Event Description

Customer reports: staff member placed an 8 fr.Silicone foley.When they were inflating the balloon with a.5 cc of the sterile water they met resistance.They tried to fully deflate the balloon and could not.They could not get the foley out of the patient.Urology had to come down and pull the foley out with the balloon still inflated.

Manufacturer Narrative

An investigation was performed for the reported customer complaint: customer reports: staff member placed an 8 fr.Silicone foley.When they were inflating the balloon with a.5 cc of the sterile water they met resistance.They tried to fully deflate the balloon and could not.They could not get the foley out of the patient.Urology had to come down and pull the foley out with the balloon still inflated.No injury to the patient was reported.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.One (1) sample was received for evaluation.The sample was visually inspected and functionally tested.Visual inspection observed no damage to the balloon.Functional testing results concluded no fault found, as the sample was able to be inflated and deflated without issue.The reported customer complaint could not be confirmed.A root cause or probable root cause could not be determined.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: DOVER
• Type of Device: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 1113 cuidad; tijuana,na 22444 ; MX 22444
• MDR Report Key: 7723962
• MDR Text Key: 115366936
• Report Number: 9612030-2018-00134
• Device Sequence Number: 1
• Product Code: FCM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2021
• Device Model Number: 8887603085
• Device Catalogue Number: 8887603085
• Device Lot Number: 6176338
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2018
• Patient Sequence Number: 1