MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 41 CM (16") APPX 2.7ML, EXT SET TUBING PUR AMBRATE, SPIKE, Y-CLAVE®, LUER CHECK; STOPCOCK, I.V. SET

Catalog Number 011-H1225

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation however, investigation is not yet complete.

Event Description

The event occurred on an unspecified date and involved a 41 cm (16") appx 2.7ml, ext set tubing pur ambrate, spike, y-clave¿, luer check valve.The customer reported a leak on an etoposide preparation made for the american hospital, at the injection site (drip flow when unclamped by the nurse) who then put a cap on it.The customer further reported that the event was observed during use on a patient, but there was no undesirable clinical consequences and nobody was harmed as a consequence of the event.There was no delay in therapy and this one has been completed.There was no blood loss considered clinically significant.The drug administered was etoposide accord 200 mg/10 ml solution for injection ucd (b)(4).There was no need for medical intervention to the healthcare professional because this one was protected by gloves and a mask.There was no direct exposure and no signs of exposure.The leak did not come into contact with the patient.There was no need to clean up according to facility protocol with a specific kit, only the perfusion foot and on the ground about ten drops, not reclamped.The patient's condition before, during and after the incident was identical.The patient received the full intended dose.No other information was provided.

Manufacturer Narrative

Received one (1) used 011-h1225 extension set tubing for inspection.A dead end cap was mated to the y-clave as received.The dead end cap was removed and a stickdown was observed at the y-clave.The set was leak tested per product specifications.There was leakage from the y-clave.The y-clave was disassembled.The internal spike was bent and broken.The reported complaint of leakage can be confirmed due to the stickdown.The probable cause of the stickdown is due to access with an incompatible mating device.The directions for use states: do not use needles or caps on clave.The clave connector is compatible with luers with an internal diameter (id) between 1.55mm and 2.8 mm.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 41 CM (16") APPX 2.7ML, EXT SET TUBING PUR AMBRATE, SPIKE, Y-CLAVE®, LUER CHECK
• 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: 18727772
• MDR Text Key: 336642191
• Report Number: 9617594-2024-00163
• Device Sequence Number: 1
• Product Code: FMG
• 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: 04/03/2024

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-H1225
• Device Lot Number: 13802868
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 04/03/2024
• 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: ETOPOSIDE 200 MG/10 ML SOL FOR INJECTION, ACCORD.