MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Model Number MC9079

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.Additional contact person from ufmw ¿ (b)(6).

Event Description

A user facility mandatory medwatch was received that stated, ¿patient with a single lumen picc line was found to have air in line a total of 5 times during the 12 hour shift, and was found to have blood backed up in line for a total of 2 times.Both the air and the blood were able to be cleared from the line without the need to open the line to the patient.¿  additionally, the event occurred on an unspecified date in (b)(6) 2020 in the patient¿s room at the hospital.There was patient involvement and no patient harm was reported.

• Brand Name: 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER
• 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: 11267471
• MDR Text Key: 245099985
• Report Number: 9617594-2021-00023
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709078161
• UDI-Public: (01)00887709078161(17)250601(10)4915987
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/05/2021

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 Model Number: MC9079
• Device Catalogue Number: MC9079
• Device Lot Number: 4915987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• 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
• Patient Age: 11 DA