MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH GOLD PAED 2W 3ML SIL STR H 08; CATHETER, UROLOGICAL

Model Number	IPN050421
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
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
Complaint description: when performing the balloon test on the 2-way foley probe no.16 with 10ml distilled water, it was found that when removing the water from the balloon, it did not deflate, making it impossible to use the product and discarding it and opening a new probe.
Additional Manufacturer Narrative
Qn# (b)(4).The batch card(s) for the complaint lot(s) was reviewed and product released met specification.Complaint reported that "when performing the balloon test on the 2- way foley probe no.16 with l0ml distilled water, it was found that when removing the water from the balloon, it did not deflate, making it impossible to use the product and discarding it and opening a new probe".There was no actual or representative complaint sample returned for evaluation, thus no physical assessment was conducted for this complaint and investigation was based on document review.Non-deflation could be occurred due to several reasons such as it was being bent or kinked during the usage, improper fixation of syringe to the valve or excessive pressure applied during deflation process.Besides that, clamping with hard object, heavy encrustation of salt deposits and the use of inflating fluids such as non-sterile water or saline also may lead to such problem.Furthermore, the balloon with low fill volume than the recommended tends to have the problem.In a standard practice, an empty syringe without plunger is also recommended to be used to drain off the fluid by gravity and avoid creation of vacuum effect and ease deflation process.However, without returned sample, the actual phenomenon which could lead to non-deflation could not be determined and associate it with any of the above-mentioned root cause.Non-deflation could be occurred due to various reasons.However, in the absence of returned sample and limited information available on this complaint, further investigation could not be conducted.
Event or Problem Description
Complaint description: when performing the balloon test on the 2-way foley probe no.16 with 10ml distilled water, it was found that when removing the water from the balloon, it did not deflate, making it impossible to use the product and discarding it and opening a new probe.

• Brand Name: RUSCH GOLD PAED 2W 3ML SIL STR H 08
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11338077
• Report Number: 8040412-2021-00054
• Device Sequence Number: 3472797
• Product Code: KOD
• UDI-Device Identifier: 14026704303066
• UDI-Public: 14026704303066
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 01/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2025
• Device Model Number: IPN050421
• Device Catalogue Number: 180003080
• Device Lot Number: 20B21
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1