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

Model Number	IPN050125
Medical Device Problem Codes	Off-Label Use (1494); Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was used off-label based on the ifu.The device has not been returned for investigation.
Event or Problem 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.
Additional 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 or Problem 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
• 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: 15337375
• Report Number: 8040412-2022-00255
• Device Sequence Number: 20564865
• Product Code: EZL
• UDI-Device Identifier: 04026704307968
• UDI-Public: 04026704307968
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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: 09/28/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Age: 3 YR
• Patient Sex: Unknown