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

Catalog Number SURGICAL UNKNOWN

Device Problem Deflation Problem (1149)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

Qn# (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 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.

Event 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.

Manufacturer Narrative

(b)(4).

• Brand Name: FOLEY CATHETER
• Type of Device: 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19176825
• MDR Text Key: 341156036
• Report Number: 8040412-2024-00118
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 04026704307968
• UDI-Public: 04026704307968
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: SURGICAL UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.