MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 53 CM (21") ADD-ON 150 ML BURETTE SET (CLAVE¿, SHUT-OFF), VENTED CAP; STOPCOCK, I.V. SET

Catalog Number 011-C7014

Device Problems Contamination (1120); Particulates (1451)

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

Event Date 04/04/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Event Description

The incident involved a 53 cm (21") add-on 150 ml burette set (clave¿, shut-off), vented cap between 04-apr-2023 and -5-apr-2023.The reporter stated that four sets, upon opening, were noted to have discoloration and dark particulate on the shut-off valve within the burette.There was no patient involvement, no patient harm, and no delay in therapy.This is the fourth of four incidents.

Manufacturer Narrative

The discoloration of the 011-c7014 burette shut-off float latex free diaphragm was confirmed on one of the two returned samples.The complaint of visible particulate was not confirmed, just a shut-off float diaphragm which was a dark amber color.Both 011-c7014 burettes were functionally tested and both burette shut-off floats performed as expected even though the latex free diaphragm of one of them was discolored.The probable cause of the latex free diaphragm discoloration is not known but did not affect product function.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9: device returned to manufacturer 08-jun-2023.

• Brand Name: 53 CM (21") ADD-ON 150 ML BURETTE SET (CLAVE¿, SHUT-OFF), 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: 16823822
• MDR Text Key: 314100941
• Report Number: 9617594-2023-00158
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619005061
• UDI-Public: (01)00840619005061(17)261001(10)5632740
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-C7014
• Device Lot Number: 5632740
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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