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

Model Number	IPN050169
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
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
It was reported that the foley catheter balloon popped.There was minimal harm, a little bit of blood noted.The patient did experience some discomfort at the time of the event.
Additional Manufacturer Narrative
Qn#(b)(4).There was no complaint device returned for investigation.Therefore, no physical assessment could be conducted, investigation will be based on document review.Based on complaint statement, the balloon had burst.Burst balloon may happen due to various reasons such as contact with sharp object during use, overinflating or contact with contradict lubricants.Balloon could also burst because of balloon had encounter with bladder or kidney stone during use for patient with bladder or kidney stone history.Based on literature, salty like sediment could also possibly lead to balloon tear.((b)(6) (2003): deflation of a foley catheter balloon, nursing standard which stated that encrustation stick on the catheter balloon may be break into small particles and scratch the catheter surface and patient urethra resulting into bleeding, scarring or trauma.In our current standard operating procedure, the products are subjected to 100% visual inspection and any defective raw balloon will be culled out before sent to the next process.Upon completion of assembly process, the finished catheter will be again subjected to 100% balloon inspection and 20 minutes leak test.Catheter with defective balloon will be culled out during this process.In conclusion, in the absence of any actual or representative sample, f urther investigation could not be conducted to identify the actual root cause of this reported failure.Therefore, this complaint could not be confirmed.
Event or Problem Description
It was reported that the foley catheter balloon popped.There was minimal harm, a little bit of blood noted.The patient did experience some discomfort at the time of the event.

• Brand Name: FOLEY CATHETERS
• Common Device Name: CATHETER, RETENTION TYPE, BALL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15826824
• Report Number: 8040412-2022-00321
• Device Sequence Number: 6155316
• Product Code: EZL
• UDI-Device Identifier: 04026704334957
• UDI-Public: 04026704334957
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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: IPN050169
• Device Catalogue Number: 170630160
• Device Lot Number: KME22D3632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown