MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 43 CM (17") APPX 5.3 ML, PUR EXT SET W/SPIKE W/VALVE, Y-CLAVE, 0.2 MICRON FILTE; STOPCOCK, I.V. SET

Catalog Number 011-H2609

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.Without the return of the sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.

Event Description

The event involved a 43 cm (17") appx 5.3 ml, pur ext set w/spike w/valve, y-clave¿, 0.2 micron filter, clamp, bcv and luer lock where drops were noted to leak from the filter solder during infusion of an unspecified chemotherapy.The device was in use for 2 minutes.There was patient involvement, and although there was a report of unprotected exposure to chemotherapy, there were no adverse events, no blood loss, no negative consequences on the operator, and no need for medical intervention.This is the first of two incidents for this event.

• Brand Name: 43 CM (17") APPX 5.3 ML, PUR EXT SET W/SPIKE W/VALVE, Y-CLAVE, 0.2 MICRON FILTE
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 10680452
• MDR Text Key: 211486408
• Report Number: 9617594-2020-00446
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619020019
• UDI-Public: (01)00840619020019(17)241001(10)4418225
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H2609
• Device Lot Number: 4418225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1