MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ADMIN SET W/FLOW CONTROLLER, 2 CLAVE¿ CLEAR; STOPCOCK, I.V. SET

Catalog Number 011-MC330620

Device Problem No Flow (2991)

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

Event Date 03/12/2024

Event Type  malfunction  

Event Description

The event involved an admin set w/flow controller, 2 clave¿ clear where it was reported the infusion syringes do not allow the fluid to flow through the pipe.The status of the product at time of event was during infusion.The length of time device was in use was 5 minutes.The device was changed out/replaced with no further problems encountered.The current status of patient was returned to baseline condition.The reporter stated that, the product was stored in its original box in the storage room.There were no cuts, holes or defects noted on the product.There was patient involvement and a delay in critical therapy.No patient harm was reported.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

• Brand Name: ADMIN SET W/FLOW CONTROLLER, 2 CLAVE¿ CLEAR
• 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: 19079287
• MDR Text Key: 340688468
• Report Number: 9617594-2024-00391
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709098442
• UDI-Public: (01)00887709098442(17)280901(10)13774369
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC330620
• Device Lot Number: 13774369
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2023
• 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 INFUSION, UNK MFR