MAUDE Adverse Event Report: COVIDIEN KENGUARD INTL FOLEY TRAY 16FR; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	13716
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2019
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported a patient had to be returned to the operating block to remove the catheter/probe as the balloon would not deflate.A piece of urethral catheter was introduced to try to pierce the balloon with no success.10ml of sterile water was re-injected to burst the balloon with no success.A cystoscopy was performed, and the presence of the inflated balloon was confirmed.Forceps and a gastric biopsy with a needle were used to pierce the center of the balloon which was successful.

• Brand Name: KENGUARD INTL FOLEY TRAY 16FR
• 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: 8743654
• Report Number: 9612030-2019-02208
• Device Sequence Number: 2280463
• Product Code: KNX
• UDI-Device Identifier: 10884521051515
• UDI-Public: 10884521051515
• 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): 06/28/2019

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: 13716
• Device Catalogue Number: 13716
• Device Lot Number: 1812207964
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1