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

Model Number	8944MF
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2020
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
The customer reported that there was difficulty removing the catheter.The balloon appeared to be unable to deflate.No patient injury reported.
Additional Manufacturer Narrative
H3 evaluation summary a device history record (dhr) review could not be performed because a lot number could not be provided.Two catheters were received for evaluation.The reported condition of the balloon not able to deflate and difficult to remove, could not be confirmed visually or functionally due to the conditions of the catheter.The catheter was received cut from the balloon for removal from the patient.The affected component is produced by an external supplier.This site¿s process only consists of a pick and place operation for this material.An investigation was requested to the manufacturer.The results will be documented when the results are received from the supplier.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
The supplier received two samples for their investigation.The samples arrived with the balloon torn, possibly from a catheter removal procedure.Both samples were examined under a magnifying camera and there were no abnormalities observed on the dinking eye.The hard valve was removed from both samples and installed on a new catheter to test the functionality of the hard valves.The balloon of the new catheter was deflated normally, indicating that there are no issues with the valves.Because the samples were received in an inadequate condition, further analysis could not be completed.The reported condition could not be confirmed visually or functionally at this time due to the conditions of the catheters.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: CURITY ANT-REF 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: 10744303
• Report Number: 9612030-2020-02679
• Device Sequence Number: 16586341
• Product Code: KNX
• UDI-Device Identifier: 10884521050648
• UDI-Public: 10884521050648
• 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,Followup
• Report Date (Section B): 09/22/2021

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
• Operator of Device: No Information
• Device Model Number: 8944MF
• Device Catalogue Number: 8944MF
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 10/23/2020; 10/23/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 02/12/2021; 09/22/2021
• Patient Sequence Number: 1