MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH GOLD 2W 5ML SIL STR H 16; CATHETER, RETENTION TYPE, BALLOON

Model Number	IPN050513
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the "nurse tried to remove foley catheter via using a syringe to deflate the balloon, but he was not able to do it.Then, he tried by cutting the lumen use to fill the balloon to deflate it.He was not able to remove the solution from the balloon either.Doctor was called.He used a wire and a urology kit.After procedure, patient was found in good health condition.Patient released from the hospital." no patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided photos for evaluation.The manufacturing site reports "there was no sample provided, only photo was available.Photo shows complaint sample deflated when inflation valve was cut.In conclusion, non-deflation could be occurred due to various reasons.However, in the absence of returned sample on this complaint, further investigation could not be conducted and therefore complaint is not confirmed.".
Event or Problem Description
It was reported that the "nurse tried to remove foley catheter via using a syringe to deflate the balloon, but he was not able to do it.Then, he tried by cutting the lumen use to fill the balloon to deflate it.He was not able to remove the solution from the balloon either.Doctor was called.He used a wire and a urology kit.After procedure, patient was found in good health condition.Patient released from the hospital." no patient harm or injury.The patient status is reported as "fine".

• Brand Name: RUSCH GOLD 2W 5ML SIL STR H 16
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• 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
• MDR Report Key: 17361375
• Report Number: 8040412-2023-00293
• Device Sequence Number: 14956576
• Product Code: BTR
• UDI-Device Identifier: 14026704302229
• UDI-Public: 14026704302229
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2023

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: Health Professional
• Device Model Number: IPN050513
• Device Catalogue Number: 180705160
• 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: 07/03/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/22/2023
• 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
• Patient Sex: Unknown