MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 142560488

Device Problems Fluid/Blood Leak (1250); Separation Failure (2547)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2023

Event Type  malfunction  

Event Description

The event involved a primary plum set, 0.2 micron filter, prepierced y-site, polyethylene lined light resistant tubing, distal microbore tubing, secure lock, 104 inch in which the reporter stated that the device was leaking.The customer reported that during phyxol infusion, after patient returned form washroom, water stains (20x25cm) noted on bed sheet and patient's pants (around right hip and upper right thigh).After checking the plum set, the tubing was found not completely sealed into connector.There was patient involvement; harm was not reported as a consequence of this event.

Manufacturer Narrative

The device is not available for evaluation, however, a photo sample is.Investigation is not yet complete.E1 - extension number - (b)(6).

Manufacturer Narrative

A photo was returned showing the tubing separated from the secure lock male adaptor.The reported complaint of separation on the 142560488 can be confirmed.The probable cause is unknown.Without the return of the used sample a comprehensive failure investigation cannot be performed.Lot history review was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: PRIMARY PLUM SET, 0.2 MICRON FILTER, PREPIERCED Y-SITE, POLYETHYLENE LINED LIGHT
• 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: 18253565
• MDR Text Key: 329566185
• Report Number: 9615050-2023-00701
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005230
• UDI-Public: (01)10887787005230(17)260601(10)13650962
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

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: 142560488
• Device Lot Number: 13650962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 12/03/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 12/27/2023
• 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: PHYXOL, MFR UNK.