MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH 2W 20ML 100% SILICONE STR H 16; CATHETER, RETENTION TYPE, BALL

Model Number	IPN050169
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
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: both deflated and pulled out.One seemed to have a pin hole in the balloon and another just looked like the balloon was defective.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The manufacturing site reports "leak balloon may occur due to various reasons such as in contact with sharp object during use i.E contact with clamper, kidney dish/tray or overinflating.Balloon could also leak as a result of balloon had come in contact with bladder or kidney stone during use for patient with bladder or kidney stone history.Based on literature, salty like sediment could also possibly lead to balloon tear." the manufacturing site also reports, "a simulation test was conducted with representative samples from production.Samples were inflated with 30ml of distilled water and soak in water at 37 c for 14 days.Samples were removed from soaking after 14 days and check for any leakage.No issue was observed.Balloons are still inflated to its normal condition and shape.In our current standard operating procedure, the products are subjected to 100% visual inspection and any defective raw balloon will be discarded before sent to the next process.Upon completion of assembly process, the finished catheter will be again subjected to 100% balloon inspection and 20 minutes leak test.Catheter with defective balloon will be culled out during this process." without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Reported issue: both deflated and pulled out.One seemed to have a pin hole in the balloon and another just looked like the balloon was defective.No injury reported.Associated mdr#s: 8040412-2023-00082; 8040412-2023-00083.

• Brand Name: RUSCH 2W 20ML 100% SILICONE STR H 16
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16515827
• Report Number: 8040412-2023-00082
• Device Sequence Number: 20407639
• Product Code: EZL
• UDI-Device Identifier: 04026704334957
• UDI-Public: 04026704334957
• 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): 02/13/2023

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: IPN050169
• Device Catalogue Number: 170630160
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/05/2023
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Male