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	06/30/2021
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the registered nurse was unable to deflate the balloon to remove the indwelling urinary catheter.The attending radiologist was called in and was also unsuccessful.Urology was contacted and they were also unable to deflate the balloon.Urology used an alternate method to puncture the balloon and deflate it in order to safely remove the patient's indwelling urinary catheter.Additional information provided by the reporter on august 06, 2021 stated that the balloon was punctured using a guidewire and it ruptured with a clean tear.There was no patient harm.The patient was discharged the same day in stable condition.
Additional Manufacturer Narrative
A sample was not received for evaluation.The device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.Since the sample was not provided for evaluation, the reported issue could not be confirmed and the root cause and corrective actions could not be identified.This complaint will be closed with no further action.If a sample is received at a later date, the complaint will be reopened and updated accordingly.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
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12304410
• Report Number: 1282497-2021-10542
• Device Sequence Number: 11682743
• Product Code: FCM
• UDI-Device Identifier: 10884521016606
• UDI-Public: 10884521016606
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: 8887603085
• Device Catalogue Number: 8887603085
• Device Lot Number: 2029038
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 19 MO
• Patient Sex: Female
• Patient Weight: 11 KG