MAUDE Adverse Event Report: RUSCH GOLD 2W 30ML SIL STR H 16; CATHETER, UROLOGICAL

Model Number	IPN050533
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
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
The nurse had great difficulty in extracting the fluid from the balloon and being able to remove the catheter.Great difficulty in extracting the fluid from the balloon and being able to remove the catheter.The customer reports that they had to puncture the tube to deflate the balloon.
Additional Manufacturer Narrative
(b)(4).The batch card(s) for the complaint lot(s) was reviewed and all passed 100% inspection.An actual sample was returned for investigation.From complaint description.It was reported that "great difficulty in extracting the fluid from the balloon and being able to remove the catheter." visual examination on the catheter did not reveal any obvious defect or abnormality.There was no sign of kinking, clamp mark or collapse lumen observed throughout the shaft.The catheter then was introduced with 30ml of water by using 60ml luer tip syringe and noticed balloon could be inflated without any difficulties faced.This indicates no blockage inside the lumen.No latex particle or other foreign particle seen within the balloon.The inflation eye was normal, and no collapse of the inflation lumen observed.Leaving the inflated balloon for 30 minutes showed no sign of leak on any part of the catheter.Deflation of the balloon by connecting empty luer tip syringe barrel to the valve was smooth , spontaneous and complete.Repeat of inflation and deflation using the attached syringe gave similar observation with no problem experienced.Based on the analysis carried out on the returned sample, the catheter was fully functional upon inflation and deflation test conducted.The balloon was able to inflate and deflate without any problem.Since there was no product dis-functionality issue observed based on reported failure, therefore this complaint could not be confirmed.However, non-deflation could be occurred due to various reasons such as it was being bent or kinked during the usage, blockage inside the inflation airline, 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 of non-deflation.The balloon also should be deflated in a way of gentle aspiration of syringe without any force.Prior to deflation, ensure the foley catheter is positioned well for better balloon deflation.
Event or Problem Description
The nurse had great difficulty in extracting the fluid from the balloon and being able to remove the catheter.Great difficulty in extracting the fluid from the balloon and being able to remove the catheter.The customer reports that they had to puncture the tube to deflate the balloon.

• Brand Name: RUSCH GOLD 2W 30ML SIL STR H 16
• Common Device Name: CATHETER, UROLOGICAL
• MDR Report Key: 11305063
• Report Number: 8040412-2021-00041
• Device Sequence Number: 11083498
• Product Code: KOD
• UDI-Device Identifier: 14026704303462
• UDI-Public: 14026704303462
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 01/20/2021

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: 04/28/2024
• Device Model Number: IPN050533
• Device Catalogue Number: 180730160
• Device Lot Number: 19E13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR