MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 80" (203 CM) BIFUSE 10 DROP BLOOD SET W/170 MICRON FILTER, MICROCLAVE, HAND PUM; STOPCOCK, I.V. SET

Catalog Number B33741

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation.Without the returned device, a probable cause is unable to be determined.

Event Description

The event occurred on an unspecified date in november that involved a 80" (203 cm) bifuse 10 drop blood set w/170 micron filter, microclave¿, hand pump, rotating luer that the customer reported air in line happened to clean setup, and was not connected to the patient.There was no patient involvement, and no harm.This report captures first of two events.

• Brand Name: 80" (203 CM) BIFUSE 10 DROP BLOOD SET W/170 MICRON FILTER, MICROCLAVE, HAND PUM
• 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: 10990743
• MDR Text Key: 220929075
• Report Number: 9617594-2020-00537
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709079281
• UDI-Public: (01)00887709079281(17)250901(10)4988698
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B33741
• Device Lot Number: 4988698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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