MAUDE Adverse Event Report: COVIDIEN FOLY CATH 100 SLCON 3CC 8FR; TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)

Model Number	8887603085
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the foley catheter balloon would not deflate while inside of patient.An emergency call to a physician was made for assistance to deflate the device.Additional information was provided on (b)(6) 2021 stating that the foley did not deflate when the rn circulator attempted to deflate it.Another rn tried to deflate it but was not successful either.The surgeon attempted to help deflate it and was not able to deflate it as well.The surgeon reached out to a urologist from huntington memorial hospital to consult about the foley balloon unable to be deflated.The urologist stated that the balloon needs to be popped with a needle.The surgeon cut the foley and the balloon and was able to remove it.The surgery was cancelled after the incident and was rescheduled.The issue did not prolong the patient's hospital stay.The patient was discharged home.
Additional Manufacturer Narrative
The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.One used sample was received for evaluation.Visual evaluation was performed, but functional evaluation could not be performed because the tip of the catheter was cut off from the device making the sample inadequate to be evaluated.The reported issue could not be confirmed.Based on the available information, the root cause and corrective actions could not be identified at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: FOLY CATH 100 SLCON 3CC 8FR
• Common Device Name: TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12441192
• Report Number: 1282497-2021-10597
• Device Sequence Number: 11675407
• Product Code: FCM
• UDI-Device Identifier: 10884521016606
• UDI-Public: 10884521016606
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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: 8887603085
• Device Catalogue Number: 8887603085
• Device Lot Number: 2005915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 10/15/2021
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 35