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; STOPCOCK, I.V. SET

Catalog Number 011-H3394

Device Problem Infusion or Flow Problem (2964)

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

Event Date 05/02/2022

Event Type  malfunction  

Manufacturer Narrative

The device is available to evaluation.However; it has not yet been received.

Event Description

The event occurred at 1300 in the day hospital, during unspecified treatment (ttt), and involved a 30 cm (12") add-on set w/4 check valves, vented cap.The product does not flow through the line that remains free, however it flows through other lines without difficulty.Therefore the device was replaced, reconnected to another line, therapy was resumed and completed.However, there was cytotoxic exposure because the product was disconnected, but no need for medical intervention for the patient or operator.There was patient involvement however no harm.

Manufacturer Narrative

Received one used list #011-h3394, 30 cm (12") add-on set w/4 check valves, vented cap; lot #unknown and two used list #unknown, extension set with bag spike; lot #unknown.The complaint of no flow could not be confirmed or replicated on the returned device.Each port on the add-on set was primed and leak tested to gravity pressure.Each port was able to be primed at gravity.No occlusions noted.No leaks observed.The lot review could not be conducted because no lot number(s) was/were identified.Additional information: a5, a6, and d9 - date returned to mfg is 6/6/2022.

• Brand Name: 30 CM (12") ADD-ON SET W/4 CHECK VALVES, VENTED CAP
• 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: 14567642
• MDR Text Key: 300778808
• Report Number: 9617594-2022-00147
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2022
• 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: UNSPECIFIED CYTOTOXIC MEDICATION, MFR UNK