MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. LTXFR CYSTOSCOPY IRR; CATHETER, IRRIGATION

Model Number	654401
Medical Device Problem Codes	Break (1069); Particulates (1451)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Testing is not complete.
Event or Problem Description
The event involved a ltxfr cystoscopy irr where the prong of the continuous bladder irrigation tubing set broke off after the bag was spiked and the prong was seen floating in the fluid of the bag.There was patient involvement, but the broken prong was noticed and the tubing or bag changed out before it reached the patient.There were no fragments passing through the tubing set.There was no adverse event, no delay in critical therapy.
Additional Manufacturer Narrative
H10 - received one used list# 065440403 with the complaint of the piercing pin breaking during bag access.As received, the set was visually inspected and the piercing pin was found to be broken at the tip.No other anomalies were found during the inspection.The bag that the spike was used to access was not returned for evaluation, nor was the broken pin's tip.The dimensions of the broken spike were measured and found to be within spec where applicable.The reported complaint can be confirmed.The probable cause of the break is due to piercing pin design which has been deemed unable to withstand all clinical stresses.A device history review (dhr) for lot# 4102714 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: LTXFR CYSTOSCOPY IRR
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 9880194
• Report Number: 9615050-2020-00048
• Device Sequence Number: 14213279
• Product Code: GBX
• UDI-Device Identifier: 10887787006732
• UDI-Public: (01)10887787006732(17)220501(10)4102714
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: 05/01/2022
• Device Model Number: 654401
• Device Catalogue Number: 065440403
• Device Lot Number: 4102714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPEC SOLUTION CONTAINER, MFR UNK