MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. GOLD LATEX FOLEY, CYLINDRICAL,PAEDIATRIC; CATHETER, RETENTION TYPE, BALLOON

Catalog Number 180003-000080

Device Problem Obstruction of Flow (2423)

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

Event Date 11/01/2022

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

An associated complaint is on file.It is unclear if the details are the same for each based on the detailed description.Reported issue: medical officer was called to exchange the catheter because urine was not flowing from it.It had been inserted on (b)(6) 2022 size 8fr.5ml water for balloon inflation.The second catheter was inserted on (b)(6) 2022 at 3am by srn as leaking was noticed from the side of the urethra.It was also a size 8fr.The balloon was inflated with 5ml.Removal of the old catheter and reinsertion were smooth and uneventful.On (b)(6) 2022 pm the bladder was slightly palpable; an attempt was made to deflate the catheter by removing 5ml water but only able to extract 1ml.The catheter was unable to be removed.The doctor was able to remove approximately 3cc.Urine drained after the balloon was partially deflated.Bladder not palpable.The report states, keep cbd first and will try to remove it again next morning.On (b)(6) 2022 the pediatric surgeon saw the patient, cbd still stuck, unable to deflate the balloon.The foley catheter was cut; stylet introduced to deflate the balloon, able to remove the catheter completely but the balloon still partially deflated.The new foley catheter size inserted was 10fr.Balloon inflated with 3cc water.This is the second case that happened in icu involving pediatric foley catheter.

Event Description

An associated complaint is on file.It is unclear if the details are the same for each based on the detailed description.Reported issue: medical officer was called to exchange the catheter because urine was not flowing from it.It had been inserted on (b)(6) 2022 size 8fr.5ml water for balloon inflation.The second catheter was inserted on (b)(6) 2022 at 3am by srn as leaking was noticed from the side of the urethra.It was also a size 8fr.The balloon was inflated with 5ml.Removal of the old catheter and reinsertion were smooth and uneventful.On (b)(6) 2022 pm the bladder was slightly palpable; an attempt was made to deflate the catheter by removing 5ml water but only able to extract 1ml.The catheter was unable to be removed.The doctor was able to remove approximately 3cc.Urine drained after the balloon was partially deflated.Bladder not palpable.The report states, keep cbd first and will try to remove it again next morning.On (b)(6) 2022 the pediatric surgeon saw the patient, cbd still stuck, unable to deflate the balloon.The foley catheter was cut; stylet introduced to deflate the balloon, able to remove the catheter completely but the balloon still partially deflated.The new foley catheter size inserted was 10fr.Balloon inflated with 3cc water.This is the second case that happened in icu involving pediatric foley catheter.

Manufacturer Narrative

Qn#(b)(4).Visual examination on the returned segment did not reveal any obvious defect or abnormality.There was no sign of kinking, clamp mark or collapse lumen observed throughout the shaft.A monofilament was inserted through the drainage lumen and it could pass through the lumen till drainage eyes without any difficulties faced.Water was introduced through the drainage lumen by using hypodermic needle attached to luer tip syringe and noticed water also could pass through the lumen without any difficulties.Based on the analysis, no blockage was observed for the drainage lumen.Monofilament and water could pass through the drainage airline without any difficulties.Since there was no product dis-functionality issue observed based on reported failure, therefore this complaint could not be confirmed.

• Brand Name: GOLD LATEX FOLEY, CYLINDRICAL,PAEDIATRIC
• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15962818
• MDR Text Key: 307265577
• Report Number: 8040412-2022-00343
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 11/23/2022

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: 180003-000080
• Device Lot Number: KMA22F0468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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