MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. FOLYSIL SILICONE FOLEY CATHETER; CATHETER, RETENTION TYPE, BALL

Model Number	IPN050271
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Nurse was preparing body for removal from room, had passed of unrelated cause.When removing the catheter, the balloon would not release the last 2ml of sterile water; was able to remove the catheter due to circumstance.The patient is deceased, due to unrelated issue.The patient was deceased, so we were able to remove the catheter with the balloon still partially inflated.
Event or Problem Description
Nurse was preparing body for removal from room, had passed of unrelated cause.When removing the catheter, the balloon would not release the last 2ml of sterile water; was able to remove the catheter due to circumstance.The patient is deceased, due to unrelated issue.The patient was deceased, so we were able to remove the catheter with the balloon still partially inflated.
Additional Manufacturer Narrative
(b)(4).The provided device lot number was not in the system; therefore a dhr review could not be conducted.There was no actual complaint sample returned for further investigation.Therefore, no physical assessment could be conducted.Balloon could not be deflated may be due to several reasons.Due to there was no actual sample returned for this complaint, any further investigation was not possible.Thus, this complaint cannot be confirmed.

• Brand Name: FOLYSIL SILICONE FOLEY CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11590132
• Report Number: 8040412-2021-00097
• Device Sequence Number: 19907735
• Product Code: EZL
• UDI-Device Identifier: 04026704335039
• UDI-Public: 04026704335039
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K972184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: 08/28/2025
• Device Model Number: IPN050271
• Device Catalogue Number: 171305160
• Device Lot Number: KME20J1176
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1