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 No Flow (2991)

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

Event Date 11/02/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been requested to be returned for evaluation; however, it has not yet been received.

Event Description

The incident involved a transfer set w/clave® (green ring), 0.2 micron filter, check valve w/luer lock.The reporter stated that the tubing becomes blocked during administration and the bag does not empty completely, leading to a reduction in the dose administered to the patient.Clinical consequence on the patient: not all of the medication could be administered.The status of the product at the time of event is during the administration.There was patient involvement but unknown patient harm.

Event Description

Additional information was received from the customer on 14-nov-2023 in which it was stated that nobody has been hurt.There was a delay in therapy and treatment could not be fully administered.The therapy had not been completed.The drug administered was trastuzumab deruxtecan.There were no physical defects observed in the device.

Manufacturer Narrative

The following was returned by the customer for evaluation: one used unit.List #011-h3407, 5 units of transfer set w/clave® (green ring), 0.2 micron filter, check valve w/luer lock; lot #13706048.One (1) used.List #unknown, glucose fresenius 5% 100 ml fresenius kabi freeflex intravenous bag with trastuzumab deruxtecan; lot #13sef271.No damages or anomalies noted.Evaluation under uv light revealed no errant solvent present.The set was attempted to prime.Fluid flowed from the piercing pin into the filter but did not exit.Pressure was gradually increased until the set flowed.The reported complaint can be confirmed.The probable cause is due to a saturated filter due to infusate during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9: date returned to mfg: 14dec2023.

• 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: 18100748
• MDR Text Key: 327720934
• Report Number: 9617594-2023-00958
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619058470
• UDI-Public: (01)00840619058470(17)280701(10)13706048
• 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,Followup
• Report Date: 02/05/2024

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: 13706048
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 11/14/2023; 01/26/2024
• Supplement Dates FDA Received: 12/07/2023; 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• 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: TRASTUZUMAB DERUXTECAN, MFR UNK