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

Model Number	IPN050171
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.
Event or Problem Description
As per account, this type and size of foley catheter was inserted in one of our patients today and the balloon busted.The nurse reported using about 25cc of water when she heard a pop, not sure if this is an isolated incident.The brand is not our usual brand.
Additional Manufacturer Narrative
(b)(4), the batch card(s) for the complaint lot(s) was reviewed all samples passed qa inspection.There was no complaint sample returned for investigation.Therefore, no physical assessment could be conducted.In the absence of any actual or representative sample for investigation, we could not further investigate to identify the actual root cause of this reported failure.Therefore, this complaint could not be confirmed.
Event or Problem Description
As per account, this type and size of foley catheter was inserted in one of our patients today and the balloon busted.The nurse reported using about 25cc of water when she heard a pop, not sure if this is an isolated incident.The brand is not our usual brand.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14356129
• Report Number: 8040412-2022-00129
• Device Sequence Number: 5009784
• Product Code: EZL
• UDI-Device Identifier: 04026704334964
• UDI-Public: 04026704334964
• 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): 05/05/2022

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 Expiration Date: 04/28/2026
• Device Model Number: IPN050171
• Device Catalogue Number: 170630180
• Device Lot Number: KME21E0248
• 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: 05/05/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2024
• 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
• Patient Sex: Unknown