MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 146870489

Device Problems Break (1069); Crack (1135)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not available to be returned for evaluation; however, a photo was provided.The investigation is still pending.

Event Description

The event occurred on an unknown date involving a primary plum set, clave secondary port, clave y-site, secure lock, 103 inch where the customer stated that they had a set of iv tubing crack/break at the luer lock connector in the intensive care unit (icu), causing not only an unsecure connection to the iv port, but then causing their iv pumps to ring out in error.Moreover, they¿ve asked staff to retain any further faulty tubing that does not have controlled medications in it.The product was in use with a patient when the event occurred.It would break when attaching to the leur lock iv site connector.There was no patient harm, just a delay in critical medications.Also, the event occurred during set-up/infusion.This is the second of four events.

Manufacturer Narrative

Received one photo showing the secure lock missing from the male luer at the distal end of the set.No cracks were observed on the male luer and the secure lock was not shown in the picture.No samples were returned for investigation.The probable cause of the missing secure lock on the 146870489 primary plum set is unknown.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history report (dhr) for lot: 13605424 was reviewed and no nonconformities were found that would have led to the reported complaint.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18237894
• MDR Text Key: 329375903
• Report Number: 9615050-2023-00688
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• UDI-Public: (01)10887787005650(17)260601(10)13605424
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 146870489
• Device Lot Number: 13605424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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 CRITICAL MEDICATION, MRF UNK.; UNSPECIFIED IV PUMP, MFR UNK.