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, IV SET

Catalog Number 011-C7014

Device Problem Particulates (1451)

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

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is not yet received.

Event Description

The event involved a 53 cm (21") add-on 150 ml burette set (clave¿, shut-off), vented cap in which the customer stated that the blue disc is discolored and that the staff had seen some particles that looked like ¿mold¿ inside the burette.The customer stated that fluid was being administered; no harm was reported as a consequence of this event.

Manufacturer Narrative

One (1) used sample, item #011-c7014 was returned for evaluation.As received a small smudge outside the burette was observed.The sample was cut and it was confirmed on the disc a slight amber discoloration on the film.The smudges were wiped off from the outside, and no internal smudges were observed.Based on the amber tint observed on the film, the complaint of the discolored component can be confirmed.The probable cause of this discoloration is unknown.The probable cause of the smudge observed outside the burette is due to residuals of infusate during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 11/16/2023.

• Brand Name: 53 CM (21") ADD-ON 150 ML BURETTE SET (CLAVE¿, SHUT-OFF), VENTED CAP
• Type of Device: STOPCOCK, IV 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17817264
• MDR Text Key: 324249520
• Report Number: 9617594-2023-00749
• Device Sequence Number: 1
• Product Code: FMG
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• 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: 01/30/2024
• 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
• Treatment: UNSPECIFIED IV FLUID, MFR UNK