MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECU; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 142540489

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter phone has an extension number: (b)(6).The device is available to be returned for evaluation; however, it has not yet been received.

Event Description

The event involved a primary plum set, clave secondary port, 2 clave y-sites, 0.2 micron filter, secure lock, 112 inch where it was reported that the tubing used within their oncology clinic had a small slit in the tubing itself.At 12:20 pm, this issue was identified with a primary plum set with inline filter, and it was running with sodium chloride.The small slit is just above the cassette.It was attached to a patient; therefore, the end y connection does contain small traces of blood.There was patient involvement, and unknown patient harm reported.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECU
• 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: 18959252
• MDR Text Key: 338365008
• Report Number: 9615050-2024-00248
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 142540489
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SODIUM CHLORIDE, MFR UNK