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

Catalog Number 180003-000080

Device Problem Deflation Problem (1149)

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

Event Date 08/22/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device has not been returned for investigation but a photograph was provided.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 a pediatric patient on (b)(6) 2022 in er, had a foley 8fr, balloon inflated with 3cc sterile water.On (b)(6) 2022 patient expired while in icu and the reported caused is dengue fever.The device was pulled out after the patient's death and when the balloon was tested it did not deflate.A photograph of the defective device was provided.

Event Description

It was reported that a pediatric patient on (b)(6) 2022 in er, had a foley 8fr, balloon inflated with 3cc sterile water.On (b)(6) 2022 patient expired while in icu and the reported caused is dengue fever.The device was pulled out after the patient's death and when the balloon was tested it did not deflate.A photograph of the defective device was provided.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed and 100% passed inspection.The actual device has not been returned for investigation, but a photograph was provided.No physical investigation or assessment has been conducted on the defective part since the actual sample was not returned.Since there was no sample returned for this complaint, further investigation for the actual root cause could not be determined.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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15672912
• MDR Text Key: 305622379
• Report Number: 8040412-2022-00293
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2023
• Device Catalogue Number: 180003-000080
• Device Lot Number: 18G04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2022
• 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.
• Patient Age: 2 YR
• Patient Weight: 12 KG