MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5 UNITS OF TRANSFER SET W/CLAVE® (GREEN RING), 0.2 MICRON FILTER, CHECK VALVE W/; STOPCOCK, I.V. SET

Catalog Number 011-H3407

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/12/2024

Event Type  malfunction  

Event Description

The event involved a 5 units of transfer set w/clave® (green ring), 0.2 micron filter, check valve w/luer lock where the customer reported that the device leaked chemotherapy drug (paclitaxel) at the location of the filter during patient use.The entire dose of the medication could not be administered.There was a delay in therapy of 2 hours, for the pouch to be refabricated.There was no visible signs of damages, defects or problems with the device prior to use.There was an unprotected exposure to a dangerous product, the leak was cleaned according to the facility's protocol and a specific kit was not used in the cleaning.The patient's health condition was reported to have not changed, no one was harmed, and there was no blood loss.There was patient involvement, but harm was not reported as a consequence of this event.

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is not yet received.

Manufacturer Narrative

One (1) used sample #011-h3407 (connected with a 0.9% sodium chloride 250ml bag) was returned for evaluation 3/13/24.As received the set and the filter were observed to be broken at exit port.No additional damage or anomalies were observed.The set was primed and a stream of water from the broken filter port was confirmed.Complaint of leaks can be confirmed based on the stream of water coming from the broken port.The probable is due to unintentional bending force applied during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported compliant.Correction to h3 initial emdr stated that device problem already known, no evaluation necessary - this was an error and should have been 'other'.

• Brand Name: 5 UNITS OF TRANSFER SET W/CLAVE® (GREEN RING), 0.2 MICRON FILTER, CHECK VALVE W/
• 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: 18887887
• MDR Text Key: 337479632
• Report Number: 9617594-2024-00257
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619058470
• UDI-Public: (01)00840619058470(17)261201(10)5748327
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

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-H3407
• Device Lot Number: 5748327
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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: PACLITAXEL, MFR UNK.