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 No Flow (2991)

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

Event Date 04/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation.Without the return of the device, probable cause is unable to be determined.The device history review (dhr) for lot 12733917 was reviewed and no nonconformities were found that would have led to the reported complaint.

Event Description

The event occurred on an unspecified date in (b)(6) 2023 and involved a 41 cm (16") appx 2.7ml, ext set tubing pur ambrate, spike, y-clave¿, luer check valve.The reported issue was the blocking of infusion sets during the process of administering gemsol.011-h1225 was connected to infusomat space cyto-sets b-braun- to 3 (three) different types.Problems occurred at the beginning when the nurse started to administer medication (immediate blocking).There was no serious injury or blood loss.There was unprotected chemo exposure and patient involvement, however no report of patient harm.This captures four of four occurrences.

• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17317283
• MDR Text Key: 319721510
• Report Number: 9617594-2023-00375
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619007843
• UDI-Public: (01)00840619007843(17)271101(10)12733917
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• 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: 12733917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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: GEMSOL, UNK MFR; INFUSOMAT SPACE CYTO-SETS BRAUN