MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH GOLD 2W 5ML SIL STR H 22; CATHETER, UROLOGICAL

Model Number	IPN050519
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
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
The balloon deflated and the catheter expelled from his body.
Additional Manufacturer Narrative
(b)(4).The batch card(s) for the complaint lot(s) was reviewed and product released met specification.There was no actual or representative complaint sample returned for evaluation, thus no physical assessment was conducted.Leak balloon could be occurred due to several reasons.However, in the absence of returned sample and limited information available on this complaint, further investigation could not be conducted and therefore complaint is not confirmed.
Event or Problem Description
The balloon deflated and the catheter expelled from his body.

• Brand Name: RUSCH GOLD 2W 5ML SIL STR H 22
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11655565
• Report Number: 8040412-2021-00116
• Device Sequence Number: 3606447
• Product Code: KOD
• UDI-Device Identifier: 14026704302281
• UDI-Public: 14026704302281
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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: 05/28/2025
• Device Model Number: IPN050519
• Device Catalogue Number: 180705220
• Device Lot Number: 20F04
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1