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

Catalog Number 170605-000120

Device Problem Break (1069)

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

Event Date 09/19/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the urologist claimed that the balloon of the foley was broken 1-2 days after being inserted to the patient.No patient harm reported.

Manufacturer Narrative

Qn#(b)(4).The batch card(s) for the complaint lot(s) was reviewed and passed qa inspection test.An actual sample was received for investigation.It was reported that balloon of the foley was broken 1-2 days after being inserted to the patient.Visual examination was conducted on the returned sample, and it was observed that the catheter was broken into 2 parts (funnel and shaft).Besides that , no other abnormalities observed.The balloon was still intact and in good condition.Both the catheter shaft and funnel were examined using dino-lite to analyze the damaged area and torn edges.Based on observation, the torn shaft surface was jagged and uneven.Review on the funnel portion reveals same cutting edges in which suggesting that the tube was once well attached to the funnel.Further investigation, the returned sample was inflated by using hypodermic needle on 12ml luer syringe and observed the balloon was able to inflate properly without having any issue.Attempt to deflate the balloon also observed no difficulties during removing the hypodermic needle from the lumen.Catheter broke may occur due to various reasons such as catheter was in contact with sharp or pointed object that may deteriorate the catheter.Nevertheless, as part of our initiative, positive released test was conducted at injection molding process.A maximum of 8 pieces of catheter from each batch were tested using weight load during start and stop of injection molding process.This is to test the bonding strength between the funnel and tube.Batches that pass this test are subjected for release.Besides that, 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 during this process.In summary, based on the investigation conducted, the balloon of the returned sample did not exhibit any sign of damage and failure to perform as intended.Therefore, this complaint could not be confirmed.

Event Description

It was reported that the urologist claimed that the balloon of the foley was broken 1-2 days after being inserted to the patient.No patient harm reported.

• 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: 15527210
• MDR Text Key: 300995595
• Report Number: 8040412-2022-00287
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 170605-000120
• Device Lot Number: KME20H2643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2022
• 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