MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL; CATHETER, RETENTION TYPE, BALLOON

Catalog Number 170605-000160

Device Problem Break (1069)

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

Event Date 10/19/2022

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

Reported issue: the urologist claimed that the balloon of the foley was broken 1-2 days after being inserted into the patient.There was no injury reported.

Event Description

Reported issue: the urologist claimed that the balloon of the foley was broken 1-2 days after being inserted into the patient.There was no injury reported.

Manufacturer Narrative

(b)(4).No actual or representative sample was returned for investigation.Based on the complaint statement "the balloon of the foley was broken 1-2 days after being inserted to the patient", the catheter balloon could have been burst during use.Review of the photo provided showed on all parts of the catheter are still in-tact.Balloon was in deflated condition.A part of the catheter, especially the proximal side appeared slightly brownish/yellowish when compared to the distal part of the catheter which is transparent.When the photo was closely reviewed, it was unable to reveal its actual condition.The balloon is still in-tact to the shaft and no obvious defect was able to be observed.In the absence of actual sample, the burst on the balloon could not be observed clearly.Burst balloon may happen due to several reasons such as being in contact with sharp object during use i.E., contact with clamper, kidney dish/ tray, overinflating or contact with contradict lubricants such as oil based antiseptic phenols or their derivatives, grease, petroleum jelly, petroleum spirit, paraffin or other relative's compounds.Balloon could also burst as a result of balloon had come in contact with bladder or kidney stone during use for patient with bladder or kidney stone history.In the absence of any actual or representative sample for investigation, further investigation could not be conducted to identify the actual root cause of this reported failure.Moreover, based on the photo provided by the complainant, it could not be observed clearly that the balloon burst.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15825388
• MDR Text Key: 304805348
• Report Number: 8040412-2022-00322
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 170605-000160
• Device Lot Number: KME21D1877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 12/15/2022
• Supplement Dates FDA Received: 12/15/2022
• 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: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED