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

Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event 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.An associated complaint is on file.

Event 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.An associated complaint is on file.

Manufacturer Narrative

Qn#(b)(4) the batch card(s) for the complaint lot(s) was reviewed showed 100% leak test was conducted and no leak product was found.Complaint reported that "2nd catheter inserted on (b)(6) 2022 at 3am by srn as they noted leaking from side of urethra, also size 8fr.Water 5mls used to inflate balloon (srn) removal of old catheter and reinsertion were smooth and uneventful.Medical officer called to exchange urine catheter as urine was not flowing out and bladder palpable suspected blocked.1st catheter inserted on (b)(6) 2022.(size 8fr)." no sample was returned for investigation.Thus, no physical investigation or assessment can be conducted on the defective tubes and investigation will be based on document review.Blockage could occur if the lumen has collapsed due to clamping action or the catheter had been stacked with weight object.This tends to give a higher pressure and directly cause the catheter lumen to become collapsed and block airline as foley catheter has been made from 100% natural rubber which is soft and flexible.Reviewing the manufacturing process, no potential cause could have contributed to the problem.All products were subjected for 100% inspection of leak test, inflation and deflation test.The defect related to functionality of the product will be culled out during inspection.In conclusion, there is limited information on the complaint and furthermore no physical investigation, or assessment has been conducted on the defective part.Therefore, no further investigation was done to determine the actual root cause to the phenomena experienced by user.Based on the investigation, the complaint is not 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: 15960767
• MDR Text Key: 306205010
• Report Number: 8040412-2022-00339
• 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?: Yes
• 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: 01/20/2023
• Supplement Dates FDA Received: 01/20/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR