MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. LTXFR NV TUR Y-SET; CATHETER, IRRIGATION

Model Number 654301

Device Problems Break (1069); Particulates (1451)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to return for evaluation.It has not been received.

Event Description

The event involved a ltxfr nv tur y-set 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.

Manufacturer Narrative

No product samples or videos were returned for evaluation.Two images were returned which show sets that appear to have broken piercing pin tips.The lot history could not be reviewed as no lot number was provided.The reported complaint can be confirmed, the probable cause cannot be determined from the information provided.

• Brand Name: LTXFR NV TUR Y-SET
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 9880180
• MDR Text Key: 186803982
• Report Number: 9615050-2020-00049
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 654301
• Device Catalogue Number: 065430401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPEC SOLUTION CONTAINER, MFR UNK