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 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

One used sample (b)(6) was returned for evaluation.As received an unknown solution residual was observed on 0.2 micron filter and the inlet filter appeared to be wetted out.No additional damage or anomalies were confirmed.The set was primed and tested as per procedure and a leak coming from the inlet filter vent was confirmed.No additional leaks along the device were observed.Complaint of leaks can be confirmed based on the used physical sample evaluation.The probable cause of the leaks is typically due to a temporary or complete loss of hydrophobic properties of the filter vent material due to an infusate interaction during use.A device history report (dhr) lot # review could not be conducted because no lot number(s) was/were identified.Additional contact information: (b)(6).

Event Description

The event involved a 22 cm (8.5") ext set w/0.2 micron filter, clamp, rotating luer where it was reported that the unspecified iv solution leaked from the air vent during infusion.The set was replaced, and therapy resumed.There was patient involvement, no 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: 18768394
• MDR Text Key: 336978161
• Report Number: 9617594-2024-00193
• 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: 02/23/2024

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: 011-C32029
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/23/2024
• 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 IV SOLUTION, MFR UNK.