MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH 2W 10ML 100% SILICONE STR H 20; CATHETER, RETENTION TYPE, BALL

Model Number	IPN050150
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that she had two foley catheters that she tried to use but both were defective in the balloon area.The first foley deflated immediately after inserting it causing leakage; the second foley lasted about an hour.There was no reported injury.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
The customer reported that she had two foley catheters that she tried to use but both were defective in the balloon area.The first foley deflated immediately after inserting it causing leakage; the second foley lasted about an hour.There was no reported injury.
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.Therefore, no physical assessment could be conducted.Due to no actual sample returned for this complaint, any further investigation was not possible.Moreover, lot number is not provided, hence dhr review could not be carried out.Therefore, this complaint could not be confirmed.

• Brand Name: RUSCH 2W 10ML 100% SILICONE STR H 20
• 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: 15692441
• Report Number: 8040412-2022-00295
• Device Sequence Number: 7337929
• Product Code: EZL
• UDI-Device Identifier: 04026704308033
• UDI-Public: 04026704308033
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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: Lay User/Patient
• Device Model Number: IPN050150
• Device Catalogue Number: 170605200
• Device Lot Number: UNKNOWN
• 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: 10/11/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 11/30/2022
• 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: N/A.
• Patient Sex: Female