MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 32 CM (13") EXT SET W/4-WAY STOPCOCK, CHECK VALVE, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number 011-H3745

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/26/2022

Event Type  malfunction  

Event Description

The event involved a 32 cm (13") ext set w/4-way stopcock, check valve, rotating luer where it was reported that during chemotherapy infusion, a leakage occurred at the connection of the extension.The amount of cytotoxic lost during the leak is estimated to be significant because patients were sleeping and could not report the leak.The leak was in contact with the patient, there was an unprotected chemo exposure for the patient.The patient did not receive the full intended dose.There was patient involvement but no report of human harm.This is the fourth of five events.

Manufacturer Narrative

The device is available for evaluation, it has not been received.

Manufacturer Narrative

Additional information: d9 - date returned to mfg is 10/4/2022.Received fifteen new 011-h3745 extension sets for inspection.Each set was tested according to design specifications.There was no leakage.The reported complaint was unable to be replicated or confirmed.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 32 CM (13") EXT SET W/4-WAY STOPCOCK, CHECK VALVE, ROTATING LUER
• 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: 15433656
• MDR Text Key: 301244993
• Report Number: 9617594-2022-00274
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619027117
• UDI-Public: (01)00840619027117(17)261101(10)5679660
• 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: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3745
• Device Lot Number: 5679660
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• 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: UNSPECIFIED CHEMOTHERAPY, MFR UNK