MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED SECONDARY EXTENSION SET W/ MANIFOLD; STOPCOCK, I.V. SET

Catalog Number UNKNOWN

Device Problems Disconnection (1171); Leak/Splash (1354)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2022

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.If a return or any additional information is later received, then a supplemental emdr will be submitted at that time.

Event Description

The complaint/event involved an unspecified disposable product which contained a manifold.A registered nurse was preparing to administer intravenous piggy back (ivpb) through a manifold after an administration of voriconazole ivpb.Upon preparing to attach a new secondary tubing to the manifold, the slip tip attachment connecting manifold tubing and the luer lock cap of the manifold connected to the voriconazole became disconnected from the tubing and voriconazole.The disconnected part from the manifold (at the point of the failed slip connector) splashed into the nurse's eye.The nurse ensured patient/scene safety, and then went to rinse her eye.There was no other clinical consequences or harm reported.

• Brand Name: UNSPECIFIED SECONDARY EXTENSION SET W/ MANIFOLD
• 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: 19044908
• MDR Text Key: 340117626
• Report Number: 9617594-2024-00372
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 MEDICATION VIA ICPB, MFR UNK.; VORICONAZOLE IVPB, MFR UNK.