MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. FOLEY CATHETERS; CATHETER, RETENTION TYPE, BALL

Model Number	IPN050125
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported issue: this is the second defective catheter found on the unit of the same size.This one was found damaged before use.The damage is the guide wire has poked through the silicone material of the catheter making it defective.This would have caused trauma to the patient if used in this condition.The other broke off after insertion into a patient at the vertex where the catheter and balloon chamber converge.This caused delay in treatment and the trauma of removing the broken catheter and replacing a new one into the pediatric patient.We did not keep the broken one because it was exposed to bodily secretions.It was disposed.
Additional Manufacturer Narrative
(b)(4).No actual or representative sample was returned for investigation.Only a photograph was provided.Therefore, the complaint investigation is based on document review and the photograph provided.From the complaint description, it was reported that guide wire has poked through the silicone material of the catheter making it defective.However, from the photograph provided, it could not be observed clearly if the stylet wire protruded the catheter to indicate the evidence of the failure.A protruded stylet wire most likely to happened when it was not inserted fully to the tip of the catheter.However, the stylet wire can be removed and re-inserted into the catheter without any issue.Review of the manufacturing process, upon completion of inspection and cleaning process, the catheter will be assembled with stylet wire and pack into an inner bag.Each catheter will be inspected for such defect as to ensure no protruded stylet wire was shipped to the customers.With reference to product ifu, the indication and guideline for product and stylet wire inspection is also included to prevent such incident.In conclusion, based on the photograph provided, it could not be observed clearly that the guide wire was protruded from the drainage eye of the catheter.Protruded stylet/guide wire most likely to occur when it was not inserted correctly, or the tube was bended or curved.However, further investigation could not be conducted to determine the actual root cause of the phenomena experienced by user as no sample was returned.Therefore, this complaint could not be confirmed.
Event or Problem Description
Reported issue: this is the second defective catheter found on the unit of the same size.This one was found damaged before use.The damage is the guide wire has poked through the silicone material of the catheter making it defective.This would have caused trauma to the patient if used in this condition.The other broke off after insertion into a patient at the vertex where the catheter and balloon chamber converge.This caused delay in treatment and the trauma of removing the broken catheter and replacing a new one into the pediatric patient.We did not keep the broken one because it was exposed to bodily secretions.It was disposed.

• Brand Name: FOLEY CATHETERS
• Common Device Name: CATHETER, RETENTION TYPE, BALL
• 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: 15870132
• Report Number: 8040412-2022-00324
• Device Sequence Number: 5209609
• Product Code: EZL
• UDI-Device Identifier: 04026704307968
• UDI-Public: 04026704307968
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K972184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2024
• Device Model Number: IPN050125
• Device Catalogue Number: 170003060
• Device Lot Number: 19GE30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 12/27/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown