MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30 CM (12") ADD-ON SET W/4 CHECK VALVES, VENTED CAP; STOPCOCK, I.V. SET

Catalog Number 011-H3394

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2020

Event Type  malfunction  

Manufacturer Narrative

The customer indicated that the device was discarded.Without a returned device, a comprehensive investigation is unable to be performed.If additional information is received, a supplemental report will be submitted.

Event Description

The customer reported that there was a sealing defect on the device allowing 5-10ml of air to pass through the tubing.This required re-priming of the tubing.The event occurred during patient use, the delay for priming the tubing was less than five minutes, and there were no adverse events.The medication involved was unspecified chemotherapy.

• Brand Name: 30 CM (12") ADD-ON SET W/4 CHECK VALVES, VENTED CAP
• 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: christopher zanoni ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 9859467
• MDR Text Key: 199868074
• Report Number: 9617594-2020-00076
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619058050
• UDI-Public: (01)00840619058050(17)240501(10)4091396
• 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: 03/16/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2024
• Device Catalogue Number: 011-H3394
• Device Lot Number: 4091396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2020
• Initial Date FDA Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• 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