MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 03 ML SAFESET¿ RESERVOIR KIT W/SINGLE NEEDLELESS VALVE; CATHETER, CONTINUOUS FLUSH

Catalog Number 011-46102-55

Device Problem Separation Failure (2547)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is not yet received.

Event Description

The event involved 03 ml safeset¿ reservoir kit w/single needleless valve in which the customer reported that a fault was noted on night shift.The arterial line became disconnected during patient use.The patient was noted to be arterially bleeding into the bed (less than 10ml).Staff removed the faulty tubing from the patient and opened another arterial line; they noted this 03ml safeset resevoir kit w/single needleless valve to have the same fault.No medication was being used with the product.The product was not seen to be faulty being removed straight out of package.There was patient involvement, with delay in therapy, but no harm was reported as a consequence of this event.This report reflects 2 of the 2 occurrences.

Manufacturer Narrative

The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 03 ML SAFESET¿ RESERVOIR KIT W/SINGLE NEEDLELESS VALVE
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 18477238
• MDR Text Key: 332455385
• Report Number: 9617594-2024-00018
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00840619040659
• UDI-Public: (01)00840619040659(17)250901(10)9041849
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K932188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-46102-55
• Device Lot Number: 9041849
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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