MAUDE Adverse Event Report: COVIDIEN KENGUARD INTL FOLEY TRAY 18FR; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	13718
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
The customer reported that during an ablation procedure, the catheter's balloon was deflated and verified by the physician.Difficulty of withdrawal of the probe was noted and when it was removed they found that the balloon was slightly inflated.A little bleeding was noted at the level of the meatus and pain was noted by the patient.

• Brand Name: KENGUARD INTL FOLEY TRAY 18FR
• 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: 9309538
• Report Number: 9612030-2019-02350
• Device Sequence Number: 13986295
• Product Code: KNX
• UDI-Device Identifier: 10884521051539
• UDI-Public: 10884521051539
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 11/12/2019

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: 13718
• Device Catalogue Number: 13718
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/12/2019
• Patient Sequence Number: 1