MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UROPASS AS 13/15FR X 24 CM 5/BX

Model Number	61324BX
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not received for evaluation.The customer discarded the device.Investigation is ongoing therefore the root cause cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
It was reported that during an unknown procedure the device tip fell off into the patient.The broken tip was retrieved using a basket.The intended procedure was completed using another device with the same device model number (61324bx).There was no patient harm or injury reported due to the event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.An investigation was completed by the original equipment manufacturer (oem), including a review of the dhr.The oem determined that there was no manufacturing, material or processing related cause for this failure mode.The root cause was determined to be environmental exposure of the device, which resulted in degradation and embrittlement of the polymer.The oem did not provide the manufacturing date but did confirm that the product shipped to olympus on 05-apr-2016.

• Brand Name: UROPASS AS 13/15FR X 24 CM 5/BX
• Common Device Name: UROPASS AS 13/15FR X 24 CM 5/BX
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis lane north, suite 160; plymouth MN 55447
• MDR Report Key: 11149818
• Report Number: 3003790304-2021-00005
• Device Sequence Number: 19734719
• Product Code: KNY
• UDI-Device Identifier: 00821925035430
• UDI-Public: 00821925035430
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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 Model Number: 61324BX
• Device Lot Number: 09C1600099
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1