MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 22 CM (8.5") EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number 011-C32029

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

Five (5) used samples #011-c32029 were returned for evaluation.As received an unknown chemo drug solution inside each filter was observed, each 0.2 micron filter that both filters vent appeared to be wetted out.No mating device was returned.Each filter was tested and it was confirmed a leak from the filter vent.Complaints of leaks can be confirmed based on the physical sample evaluation.The probable cause is typically due to a temporary or complete loss of hydrophobic properties of the filter vent material due to an infusate interaction during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

Event Description

It was reported that a 22 cm (8.5") ext set w/0.2 micron filter, clamp, rotating luer generated a leak during patient use.The reporter stated, ¿the solution leaked from the air vent." the event occurred during infusion.It was also mentioned that there was no concomitant drug, no concomitant device, no bleed-back, with an unknown name of chemo drug, no bio-hazard, and unknown user facility med-watch.The device was not reprocessed/resterilized.The quantity affected is five and is available for return for evaluation.The sample was returned from clinical contact.A sample photo was not provided.There was no unprotected chemo exposure in this event.There was no patient and no healthcare provider harm.This is two of five events.

• Brand Name: 22 CM (8.5") EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19177950
• MDR Text Key: 341672206
• Report Number: 9617594-2024-00500
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619099824
• UDI-Public: (01)00840619099824(17)280201(10)13542629
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-C32029
• Device Lot Number: 13542629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• 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: UNSPECIFIED CHEMO, UNK MFR