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
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the returned device, a probable cause is unable to be determined.
Event or Problem 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
• Common Device Name: 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
• MDR Report Key: 10990743
• Report Number: 9617594-2020-00537
• Device Sequence Number: 13647508
• Product Code: FMG
• UDI-Device Identifier: 00887709079281
• UDI-Public: (01)00887709079281(17)250901(10)4988698
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/18/2020

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: 09/01/2025
• Device Catalogue Number: B33741
• Device Lot Number: 4988698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1