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

Model Number 1468728

Device Problems Material Rupture (1546); Failure to Infuse (2340)

Patient Problems Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2023

Event Type  Injury  

Event Description

The event involved a primary plum set, clave secondary port, clave y-site, secure lock, 103 inch.It was reported the fluids could not be injected into the patient due to a rupture of catheter, which caused patient discomfort or an uncontrolled condition, and had to extend their hospital stay.There was patient involvement however no harm was reported.

Manufacturer Narrative

The device is not available for investigation, however photos were provided.Investigation pending.

Manufacturer Narrative

A photo was returned showing the set.An area of the tubing was circled.There was no rupture observed.No samples or sister samples were available for investigation.The reported complaint of ruptured tubing could not be confirmed on the 14687-15 primary plum set.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history review for lot 13518721 was reviewed and no non conformities were found that would have led to the reported complain.

• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17213951
• MDR Text Key: 317985667
• Report Number: 9615050-2023-00204
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• UDI-Public: (01)10887787005650(17)260301(10)13518721
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1468728
• Device Catalogue Number: 14687-15
• Device Lot Number: 13518721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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 FLUIDS, MFR UNK
• Patient Outcome(s): Hospitalization