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 Crack (1135); Disconnection (1171)

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

Event Date 10/01/2023

Event Type  malfunction  

Event Description

The event occurred on an unspecified date and involved a primary plum set, clave secondary port, clave y-site, secure lock, 103 inch.It was reported that they had leur locks cracked, the tubing was found disconnected from the patient and upon inspection they have identified the connection was cracked/broken.There was patient involved and no patient harm reported.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.Fda med watch report med192548 however the physical copy could not be attached as it is pending.

Manufacturer Narrative

Received one (1) used partial (b)(4) primary plum set for inspection.A portion of the secure lock of the male luer adaptor was observed to be cracked and broken off.There was crazing observed on the plastic of the broken off portion of the secure lock.The reported complaint can be confirmed.The damage is typical of environmental stress cracking during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Device returned (b)(6) 2023.

• 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: 18179106
• MDR Text Key: 328632593
• Report Number: 9615050-2023-00664
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• UDI-Public: (01)10887787005650(17)260201(10)13493413
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 13493413
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• 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: PROPOFOL, MFR UNK