MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 126" 10 DROP PRIMARY SET W/3 MICROCLAVE®, 2 GANG 4-WAY STOPCOCKS, ROTATING LUER,; STOPCOCK, I.V. SET

Catalog Number Z3239

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2022

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.

Event Description

The incident involved a 126" 10 drop primary set w/3 microclave¿, 2 gang 4-way stopcocks, rotating luer, 1 ext.A medsun medwatch mandatory report uf/importer report # (b)(4) was received by the manufacturer.Per the report, nursing noted that the anesthesia tubing would not allow intravenous fluids (ivf) to flow.The bottom luer-lock port was not flushable.The peripheral iv (piv) itself was patent.There was no reported patient harm and only ivf noted to be running, not anesthetic medication.The original intended procedure was for iv tubing to deliver ivf and anesthetic once patient was in the operating room.There were no observed damages or anomalies with the set and/or the mating /access devices.There was patient involvement and no harm reported.

• Brand Name: 126" 10 DROP PRIMARY SET W/3 MICROCLAVE®, 2 GANG 4-WAY STOPCOCKS, 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18074220
• MDR Text Key: 327416019
• Report Number: 9617594-2023-00943
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709030473
• UDI-Public: (01)00887709030473(17)270601(10)6038095
• 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 Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: Z3239
• Device Lot Number: 6038095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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
• Treatment: UNSPECIFIED IV FLUIDS, MFR UNK