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 Problem Air/Gas in Device (4062)

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

Event Date 08/28/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, however has not been received.E1 initial reporter address: (b)(6).

Event Description

The event involved a 53 cm (21") add-on 150 ml burette set (clave¿, shut-off), vented cap where it was reported the blue disc did not occlude the line on pediatric patient in the operating theatre.This resulted in air going down the line past the burette chamber.When they tried to refill the burette, the blue disc floated to the top of the burette.There was patient involvement and no patient harm.This captures 1 of 3 occurrences.

Manufacturer Narrative

One used sample item #011-c7014 connected with an unknown, baxter viaflex 500 ml bag were returned for evaluation.As received no physical damage or anomalies were observed on the set.The set was tested as per procedure and as the burette empty the blue disc settled to the bottom avoiding air going down.Complaint of product incorporate air / allow air passage cannot be confirmed or replicated.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9 device returned to manufacturer on 11/16/2023.

• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17804232
• MDR Text Key: 324158361
• Report Number: 9617594-2023-00740
• Device Sequence Number: 1
• Product Code: FMG
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• 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: 5844640
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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