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

Catalog Number 170605-000160

Device Problem Deflation Problem (1149)

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

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending and a follow-up report will be issued after the investigation is complete.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that gp placed a catheter ch 14.During the patients shower the next day, the catheter fell out.Another gp placed a new catheter ch 16.Again it fell out during the shower.Patient again needed a new catheter.This had to be done by a doctor on duty from the hap.He placed a new catheter from a different brand ch 16 and this remained in place.

Event Description

It was reported that gp placed a catheter ch 14.During the patients shower the next day, the catheter fell out.Another gp placed a new catheter ch 16.Again it fell out during the shower.Patient again needed a new catheter.This had to be done by a doctor on duty from the hap.He placed a new catheter from a different brand ch 16 and this remained in place.

Manufacturer Narrative

Qn#(b)(4).The batch card(s) for the complaint lot(s) was reviewed and passed qa inspection.6 representative samples were returned for investigation.Visual examination was performed on the returned representative catheters and no material degradation or abnormalities observed.The entire components appeared to be in good condition.The representative samples then were inflated with 10ml of distilled water.The balloons inflated normally and no difficulties during inflation.The representative samples then deflated using an empty syringe without any problem arose.Leak balloon may happen due to several reasons such as 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 relatives' compounds.Balloon could also leak as a result of balloon had come in contact with bladder or kidney stone during use for patient with bladder or kidney stone history.Based on literature, salty like sediment could also possibly lead to balloon tear.Refer to figure 1 below adopted from an article from robinson j (2003): deflation of a foley catheter balloon, nursing standard which stated that encrustation stick on the catheter balloon may be break into small particles and scratch the catheter surface and patient urethra resulting into bleeding, scarring or trauma.In our current standard operating procedure, the products are subjected to 100% visual inspection and any defective raw balloon will be culled out before sent to the next process.Upon completion of assembly process, the finished catheter will be again subjected to 100% balloon inspection and 20 minutes leak test.Catheter with defective balloon will be culled out.In summary, the returned representative samples did not exhibit any failure of balloon leak.Based on the investigation conducted, the balloons were still able to retain its inflated condition.Therefore, this complaint could not be confirmed as stated.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15670645
• MDR Text Key: 305622064
• Report Number: 8040412-2022-00291
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• 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: KME21M3294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2022
• Was Device Evaluated by Manufacturer?: No
• 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