MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH PAED 2W 1.5ML 100% SILICONE STR 06; CATHETER, RETENTION TYPE, BALL

Model Number IPN050125

Device Problems Off-Label Use (1494); Material Perforation (2205)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was used off-label based on the ifu.The device has not been returned for investigation.

Event Description

(b)(4).Pediatric patient with foreign object in nose.Provider used rusch pediatric foley catheter to remove foreign object from nose.Upon removing the catheter from the nose, the physician reported the stylet had punctured the catheter and was sticking out of the side of the catheter.No injury to the patient was identified.

Manufacturer Narrative

Qn#(b)(4).The batch card(s) for the complaint lot(s) was reviewed and passed qa inspection.There was no actual complaint sample returned for investigation, therefore no physical assessment can be conducted.The user misused the device to remove foreign object from patient's nose where the device was designed for transurethral drainage of the bladder.In normal application of the catheter as per intended use, protruded stylet most likely to occur when it was not inserted correctly, or during re-insertion.Due to no actual sample returned for this complaint, further investigation was not possible.Therefore, this complaint could not be confirmed.

Event Description

Medwatch report# 3400690000-2022-8009.Pediatric patient with foreign object in nose.Provider used rusch pediatric foley catheter to remove foreign object from nose.Upon removing the catheter from the nose, the physician reported the stylet had punctured the catheter and was sticking out of the side of the catheter.No injury to the patient was identified.

• Brand Name: RUSCH PAED 2W 1.5ML 100% SILICONE STR 06
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15337375
• MDR Text Key: 305415704
• Report Number: 8040412-2022-00255
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 04026704307968
• UDI-Public: 04026704307968
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN050125
• Device Catalogue Number: 170003060
• Device Lot Number: KME21K1383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Age: 3 YR