MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. GOLD LATEX FOLEY, CYLINDRICAL,PAEDIATRIC; CATHETER, RETENTION TYPE, BALLOON

Model Number IPN050419

Device Problem Deflation Problem (1149)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/02/2024

Event Type  Injury  

Manufacturer Narrative

Qn # (b)(4).

Event Description

It was reported " a catheter was inserted in a female patient.During removal it was impossible to deflate the balloon and therefore impossible to remove the catheter.The doctor inflated the balloon until it ruptured before removing the catheter." additional information states that it is believe the a piece of the device is still inside the bladder of the patient and the urologist believes that natural evacuation is highly likely.The patient's current condition is reported as " good health.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported " a catheter was inserted in a female patient.During removal it was impossible to deflate the balloonand therefore impossible to remove the catheter.The doctor inflated the balloon until it ruptured before removing the catheter." additional information states that it is believe the a piece of the device is still inside the bladder of the patient and the urologist believes that natural evacuation is highly likely.The patient's current condition is reported as " good health".

• Brand Name: GOLD LATEX FOLEY, CYLINDRICAL,PAEDIATRIC
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19187712
• MDR Text Key: 341114585
• Report Number: 8040412-2024-00129
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN050419
• Device Catalogue Number: 180003-000080
• Device Lot Number: KMA22M0122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2022
• 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
• Patient Sex: Female