MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. GOLD LATEX FOLEY, CYLINDRICAL,PAEDIATR

Catalog Number 180003-000080

Device Problem Deflation Problem (1149)

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

Event Date 10/19/2021

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

Product case: non-deflation, indwelling time: 10 days.Step 1: cut the catheter, it would not work; step2: urologist inflated with sevaflurance 1 ml; no injury reported.Note: patient: female, (b)(6); hispopadia.

Manufacturer Narrative

Qn#(b)(4).The batch card(s) for the complaint lot(s) was reviewed and passed 100% inspection.A photo was provided for investigation.No actual sample was returned.Therefore, no physical assessment was conducted for this complaint and investigation will be based on document review.Further investigation could not be conducted as no sample was returned for investigation.However since the product was use not per ifu instruction it is possible that the root cause is related to user error.

Event Description

Product case: non-deflation.Indwelling time: 10 days.Step 1: cut the catheter, it would not work.Step2: urologist inflated with sevaflurance 1 ml.No injury reported.Note: patient: female, 3 years 7 month; hispopadia.

• Brand Name: GOLD LATEX FOLEY, CYLINDRICAL,PAEDIATR
• 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: 12856799
• MDR Text Key: 282276119
• Report Number: 8040412-2021-00294
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: ID
• 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: 11/02/2021

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: 19105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 12/22/2021
• Supplement Dates FDA Received: 12/27/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Sex: Female