MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC

Catalog Number 170003-000080

Device Problems Burst Container or Vessel (1074); Off-Label Use (1494)

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

Event Date 05/29/2022

Event Type  malfunction  

Event Description

Catheter being used in gastrostomy tube, silicone balloon fail/split in tube.Tube replaced.

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed and passed qa inspection.It was reported that "catheter being used in gastrostomy tube - silicone balloon fail/ split in tube." according to technical file tf-m018-3, the usage of the catheter was indicated where routine drainage of the bladder is required either postoperatively, for patients with conditions requiring urine drainage and for patients requiring the monitoring of urinary output.Similar indication for use also clearly stated on the ifu d60514 that the device was intended for routine transurethral drainage or for postoperative transurethral drainage and irrigation of the bladder under medical supervision.Foley catheters are designed and intended to be used in urine drainage instead of being used as gastrostomy tube for enteral feeding purpose.The use of foley catheters as gastrostomy tubes can result in certain complications; for example, the balloon may rupture, allowing the catheter to slip out, and distal migration of the tube can occur, which could potentially lead to obstruction of the gastric pylorus or small bowel (gowen, 1988; bankhead, et al., 2009).Use of a foley catheter as a feeding gastrostomy catheter can cause secondary coiled spring retrograde intussusception (hussain and thambidorai, 2000).Therefore the foley catheters are not recommended to be used as the replacement of gastrostomy tube.In conclusion, this product was used not as per intended use.This complaint could not be confirmed.

Event Description

Catheter being used in gastrostomy tube, silicone balloon fail/split in tube.Tube replaced.

• Brand Name: BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC
• 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: 14828494
• MDR Text Key: 300829302
• Report Number: 8040412-2022-00176
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

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: 170003-000080
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 07/29/2022
• Supplement Dates FDA Received: 08/02/2022
• 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: N/A.