MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SEE SECTION 10; STOPCOCK, I.V. SET

Catalog Number 011-H1267

Device Problem Disconnection (1171)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2023

Event Type  malfunction  

Event Description

The event involved a 28 cm (11") set per infusione per pompa con due clave® connector e perforatore con filtro which the customer reported that the valve disconnected and leaked cisplatin chemotherapy, patient infusion.There was a delay in treatment; the chemotherapy was not completed to the patient since the volume injected is unknown; resumption of full treatment during the next session.There was reported skin exposure to the healthcare professional and leak was cleaned-up by using a specific kit available in the facility.There was patient involvement, however, there was no harm reported or medical intervention needed.

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is yet to be received.Section d1 - 28 cm (11") set per infusione per pompa con due clave® connector e perforatore con filtro.

Manufacturer Narrative

One used sample was received, connected to an unknown primary plum and mating device on 8/9/23 for evaluation.As received clave and trifurcate came separated, it was confirmed with the ultra violet (uv) light, the presence of solvent inside the luer adaptor instead outside.There is a mark confirmed that the adaptor had been fully inserted inside the trifurcate, however no enough solvent was applied in the adaptor.No additional damage or anomaly were observed.Complaint of separation can be confirmed based on the physical sample evaluation.The probable cause was due to a bonding error on luer adaptor during manual process assembly.A device history review could not be conducted because no lot /number(s) was/were identified.

• Brand Name: SEE SECTION 10
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17175225
• MDR Text Key: 317992133
• Report Number: 9617594-2023-00258
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H1267
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• 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: CISPLATINMEDICATION, MFR UNK