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

Catalog Number	SURGICAL UNKNOWN
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that during use, the catheter balloon would not deflate.At the time of this report, the customer has not returned our requests for additional information.
Additional Manufacturer Narrative
(b)(4).New information received indicates that this was not a reportable event, thus, the initial mdr submitted on 24 april 2024 should be retracted.
Event or Problem Description
It was reported that during use, the catheter balloon would not deflate.At the time of this report, the customer has not returned our requests for additional information.

• Brand Name: FOLEY CATHETER
• 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: taliah shabazz ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19176856
• Report Number: 8040412-2024-00119
• Device Sequence Number: 6415739
• Product Code: EZL
• UDI-Device Identifier: 04026704307968
• UDI-Public: 04026704307968
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

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 Catalogue Number: SURGICAL UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown