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 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

Received one used 011-c32029 extension sets w/0.2 micron filters for inspection.The inlet and outlet filter vents on the 0.2 micron filter was wetted out with prior infusate.The set was leak tested per product specifications.There was leakage from the filter vents of the 0.2 micron filter.The reported complaint of leakage can be confirmed on the used 011-c32029 extension sets w/0.2 micron filters.The probable cause of leakage is due to a temporary or complete loss of hydrophobic properties of the filter vent material due to an infusate interaction during use.The device history report (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

Event Description

The event involved a 22 cm (8.5") ext set w/0.2 micron filter, clamp, rotating luer where the customer reported that an unknown chemo solution leaked from the air vent during infusion.There was no unprotected chemotherapy exposure in this event, it did not come into contact with the healthcare provider or patient.The chemo spill was cleaned up per facility protocol by a spill kit.There was no any physical damage noted on the device.There was patient involvement, but no adverse event/ patient harm and no delay in critical therapy.

• 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: 18992414
• MDR Text Key: 339257273
• Report Number: 9617594-2024-00345
• Device Sequence Number: 1
• Product Code: FMG
• 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
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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 SOLUTION, MFR UNK