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 Problem No Flow (2991)

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

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event 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.

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 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
• Type of Device: CATHETER, RETENTION TYPE, BALL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11895039
• MDR Text Key: 254892922
• Report Number: 8040412-2021-00163
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 04026704307968
• UDI-Public: 04026704307968
• Combination Product (y/n): N
• PMA/PMN Number: K972184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: IPN050125
• Device Catalogue Number: 170003060
• Device Lot Number: 20DT36
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 07/01/2021
• Supplement Dates FDA Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1