MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30 CM (12") ADD-ON SET W/4 CHECK VALVES, VENTED CAP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 011-H3394

Device Problem Disconnection (1171)

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

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.The investigation is pending.

Event Description

The event involved a 30 cm (12") add-on set w/4 check valves, vented cap where the customer reported a maladjustment at the tap junction of the device chemo tree.Disconnection of one valve.Risk of cytotoxic spill for patient and healthcare provider.The event happened around 12:00 pm.The status of the product at the time of the event is during chemotherapy.There was patient involvement ((b)(6) with file number : (b)(4)) and unknown adverse event/human harm.Bedridden patient, calm before, during and after the event.To note a hemorrhage in the morning, inducing an emergency ct angiogram for etiology research while the patient was undergoing treatment.The stretcher bearer would have been exposed to the cytotoxic (the exposed area was washed abundantly with water, but it is not known if he realized a non-compliance on his side, he was no longer there at the arrival of the reporter).No need for medical intervention for the stretcher bearer.The medication involved is 5-fu.In terms of impact on the patient, no direct harm but a dose not fully received.No medical intervention was necessary, but the pharmacist was called to keep him informed (continuation of the chemo in progress because no precise data on the dose not received).There was a delay in administration of approximately 1 hour (time of trivorex protocol carried out in the corridor where the cytotoxic was spilled and reinstallation of the patient in the room).The treatment has been resumed but part of the dose was lost.No default noted by the nurse the day before the event on the device.No cut, no hole, no tear on the device.

Manufacturer Narrative

One used sample list (b)(6) was returned for evaluation.As received a clave separation from the trifurcated was observed.The separated parts were observed through uv light and insufficient solvent coverage on the adaptor and trifurcate was confirmed.No damage or excessive force being applied was observed on the sample.Complaint of disconnection / loose connection can be confirmed.The probable cause is due to insufficient solvent applied during manual assembly at ensenada.The device history report (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 30 CM (12") ADD-ON SET W/4 CHECK VALVES, VENTED CAP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 18768578
• MDR Text Key: 336973477
• Report Number: 9617594-2024-00194
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K070532
• 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: 03/28/2024

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-H3394
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/28/2024
• 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: 5FU, MFR UNK.; TRIVOREX, MFR UNK.