MAUDE Adverse Event Report: COVIDIEN CURITY MONO-FLO 14FR WO PVPI; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	6162MF
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
Customer reports: during testing of the balloon, after indwelling the catheter, the sterile water in the balloon was unable to be pulled out.Several attempts were made however, the water was unable to be removed from the balloon.
Additional Manufacturer Narrative
A device history record could not be reviewed because a lot number could not be provided by the customer.However, all record from manufacturing lots were reviewed and ensure that products were released meeting all quality release specifications at the time of manufacture.One decontaminated drainage bag was received for evaluation.A visual inspection was completed according to the product specification procedure, however, based on the visual and functional evaluation, the reported condition was not confirmed, since the returned catheter did not present an obstruction when removing the sterilized water from the balloon.The condition reported by the customer was not confirmed.Were found in the sample received; the sample were found to perform according to quality specifications.An action plan is not considered necessary as the sample received are within specification.We will continue to monitor the process for any adverse trends that require immediate attention.

• Brand Name: CURITY MONO-FLO 14FR WO PVPI
• Common Device Name: COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10831197
• Report Number: 9612030-2020-02693
• Device Sequence Number: 11806764
• Product Code: KNX
• UDI-Device Identifier: 10884521050587
• UDI-Public: 10884521050587
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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
• Operator of Device: No Information
• Device Model Number: 6162MF
• Device Catalogue Number: 6162MF
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 01/06/2021
• Patient Sequence Number: 1