MAUDE Adverse Event Report: TELEFLEX MEDICAL BRILLANT 100% SIL FOLEY 12FR

Catalog Number 170605120

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

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

It was reported that a patient who had a hip replacement came to the recovery room after surgery.The nurse noticed that the urine catheter had been cut from the root of the catheter.The nurse managed to remove the catheter, but was not successful in reinstalling the catheter on the first time, as the patient was so much in pain and the visibility is poor.Re-catheterization was successful.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed all samples passed qa inspection.No physical investigation or assessment has been conducted on the defective catheter as no action or representative sample was returned for investigation.In the absence of any actual or representative sample, further investigation could not be conducted to identify the actual root cause of this reported failure.Therefore, th is complaint could not be confirmed.

Event Description

It was reported that a patient who had a hip replacement came to the recovery room after surgery.The nurse noticed that the urine catheter had been cut from the root of the catheter.The nurse managed to remove the catheter, but was not successful in reinstalling the catheter on the first time, as the patient was so much in pain and the visibility is poor.Re-catheterization was successful.

• Brand Name: BRILLANT 100% SIL FOLEY 12FR
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 7642087
• MDR Text Key: 112745598
• Report Number: 8040412-2018-00178
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 170605120
• Device Lot Number: 17HE32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1