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

Model Number	IPN054275
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
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
Post-operated patient on (b)(6) 2021.During the doctor visit, a deflated foley catheter cuff was detected.Fixation is done to keep the catheter in place.The next day the probe is removed by the doctor and a broken cuff is observed.It is classified as a medical device failure.Note: patient is fine, was discharged on (b)(6) 2021.The balloon is filled with 50 cc of water double distilled.The product was used according to the instructions.The intervention performed: the probe is fixed to the patient's skin with elastic gauze and cloth.
Event or Problem Description
Post-operated patient on (b)(6) 2021.During the doctor visit, a deflated foley catheter cuff was detected.Fixation is done to keep the catheter in place.The next day the probe is removed by the doctor and a broken cuff is observed.It is classified as a medical device failure.Note: patient is fine, was discharged on (b)(6) 2021.The balloon is filled with 50 cc of water double distilled.The product was used according to the instructions.The intervention performed: the probe is fixed to the patient's skin with elastic gauze and cloth.
Additional Manufacturer Narrative
(b)(4), the batch card(s) for the complaint lot(s) was reviewed and all manufactured product was 100% inspected for any cosmetic and functional failure and buy-off by quality assurance before release to the field.No sample was returned for investigation; therefore, no physical investigation could be conducted.In conclusion, the report could not be confirmed its possible root cause, since there is no returned sample for physical investigation.

• Brand Name: POSTOPERATIVE FOLEY CATHETER
• Common Device Name: CATHETER RETENTION TYPE, BALL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11495496
• Report Number: 8040412-2021-00067
• Device Sequence Number: 5512860
• Product Code: EZL
• UDI-Device Identifier: 14026704612465
• UDI-Public: 14026704612465
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K162989
• 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

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 Model Number: IPN054275
• Device Catalogue Number: 570622
• Device Lot Number: 17IE39
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2202
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1