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	05/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.
Event or Problem Description
The probe breaks when installed on the patient.Sometimes after a few hours and sometimes after a few days.They broke on sleeping, sedated little babies who did not move.The patients who had the catheters in place were all small, intubated patients under 8kg.The catheters were all size 6 french.The last patient was a cardiac surgery patient who was intubated, sedated and critical.Less than 3kg.In all cases the parts were all removed without obvious complications.New catheters were installed as was necessary to the patient's condition with extra surveillance by the nurse.I cannot recall if there were any urinary infection prophylactic antibiotics given to the patients on related to the breaks.
Event or Problem Description
The probe breaks when installed on the patient.Sometimes after a few hours and sometimes after a few days.They broke on sleeping, sedated little babies who did not move.The patients who had the catheters in place were all small, intubated patients under 8kg.The catheters were all size 6 french.The last patient was a cardiac surgery patient who was intubated, sedated and critical.Less than 3kg.In all cases the parts were all removed without obvious complications.New catheters were installed as was necessary to the patient's condition with extra surveillance by the nurse.I cannot recall if there were any urinary infection prophylactic antibiotics given to the patients on related to the breaks.
Additional Manufacturer Narrative
Qn#(b)(4).The device lot number was not provided; therefore a dhr review could not be conducted.There was no complaint sample returned for investigation, only photo available.Therefore, no physical assessment could be conducted.In the absence of any actual or representative sample for investigation, we could not further investigate to identify the actual root cause of this reported failure.Therefore, this complaint could not be confirmed.

• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14358414
• Report Number: 8040412-2022-00134
• Device Sequence Number: 4155170
• 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): 05/09/2022

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 Model Number: IPN050125
• Device Catalogue Number: 170003060
• 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: 05/09/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/28/2022
• 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
• Patient Sex: Unknown