MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 28 CM (11") ADD-ON SET W/CHECK VALVE, VENTED CAP; STOPCOCK, I.V. SET

Catalog Number 011-H3395

Device Problem No Flow (2991)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation- it has not been received.

Event Description

The event involved a 28 cm (11") add-on set w/check valve, vented cap where the customer reported that the infusion ¿tree¿, one way is obstructed and does not permit the flow from the chemotherapy bag.The obstruction is situated to the level of the connector.The device was replaced.The customer added that they observed the incident at the time of administration of the infusion, immediately upon connecting the drug to the infusion shaft.There was patient involvement but no patient harm.The product was not flowing into the tubing from the start.After this the drug could not be administered to the patient.There was a 5 minute delay in therapy.No one has been hurt and the therapy has been completed.No other information was provided.This is the fifth of five events.

• Brand Name: 28 CM (11") ADD-ON SET W/CHECK VALVE, VENTED CAP
• 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: 18950289
• MDR Text Key: 339155936
• Report Number: 9617594-2024-00320
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619058067
• UDI-Public: (01)00840619058067(17)280801(10)13740517
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3395
• Device Lot Number: 13740517
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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 CHEMOTHERAPY, MFR UNK.