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 Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Nurse reports that the catheter was placed but there was no urine output during procedure.The catheter was removed and replaced and urine returned.The original catheter was inspected and flushed.This was done to see if something may have blocked flow (ie: stones, etc).The nurse noted that there did not seem to be any eyelets at the tip of the catheter.
Additional Manufacturer Narrative
Qn#(b)(4).The batch card(s) for the complaint lot(s) was reviewed and no abnormalities found.There was no complaint sample returned for investigation.Therefore, no physical assessment could be conducted.Non-drainage could be occurred due to several reasons.However, in the absence of returned sample and limited information available in this complaint, further investigation is not able to be conducted and therefore this complaint could not be confirmed.
Event or Problem Description
Nurse reports that the catheter was placed but there was no urine output during procedure.The catheter was removed and replaced and urine returned.The original catheter was inspected and flushed.This was done to see if something may have blocked flow (ie: stones, etc).The nurse noted that there did not seem to be any eyelets at the tip of the catheter.

• 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
• MDR Report Key: 11895039
• Report Number: 8040412-2021-00163
• Device Sequence Number: 14380092
• Product Code: EZL
• UDI-Device Identifier: 04026704307968
• UDI-Public: 04026704307968
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 03/28/2025
• Device Model Number: IPN050125
• Device Catalogue Number: 170003060
• Device Lot Number: 20DT36
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1