MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14 CM (5.5") SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number 011-MC33793

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

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

Event Date 09/06/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, it has not been received.

Event Description

The event occurred at 5:30am involving a 14 cm (5.5") smallbore ext set w/microclave® clear, clamp, rotating luer where the customer reported a presence of blood around a patient during gravity infusion.A pediatric nurse observed the absence of tubing at the catheter placed on the child's forearm.The catheter's extension broke or detached at a weld joint, causing the blood to flow onto the floor, it appeared that the valve detached from the catheter.The ongoing intravenous solution was isopedia at a flow rate of 60 ml/h.The medical device was connected to a pink 20g catheter.The catheter was inserted from tuesday night, (b)(6) 2023 to wednesday, (b)(6) 2023, at 23:00, adding to it the extension 011-mc33793, a valve with extension and a standard tubing for the volumat pump during gravity infusion.At 05:00 am the antibiotics were connected.At 05:38 am the patient rang the bell to report blood on the bed.The nurse immediately redressed the bandage and placed a new catheter extension.During handling of the defective device, the nurse used biseptine.There were no changes in the patient's condition before, during or after the incident.No one was harmed when the incident occurred, no adverse event have been noted, there was, no delay in therapy, the therapy was successful after the device has been changed and the patient has received the medication planned dose.There was a blood loss, but there was no quantifiable clinically significant blood loss noted.Regarding the volumat infusion pump, the customer stated no alarm has been showed/ringed by the pump.The 20g pink catheter has been connected correctly as per manufacture's guide.There was patient involvement but no adverse events/human harm.

Manufacturer Narrative

D9 - date returned to mfg on 12/19/2023.The reported complaint of breakage was confirmed on the returned set.During visual inspection, the pressure tubing was received broken/cut off from the microclave.When the returned set was microscopically examined, a part of the tubing was found inside the microclave luer.The probable cause of the tubing breakage had occurred due to unintentional twisting or pulling force applied on the tubing during use.The device history report (dhr) for lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 14 CM (5.5") SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING LUER
• 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: 18154521
• MDR Text Key: 328399646
• Report Number: 9617594-2023-00987
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC33793
• Device Lot Number: UNKNOWN
• 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
• 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: ANTIBIOTICS, MFR UNK; BISEPTINE, MFR UNK; ISOPEDIA INTRAVENOUS SOLUTION, MFR UNK; PINK 20G CATHETER, MFR UNK; STANDARD TUBING, MFR UNK; VALVE W/ EXTENSION, MFR UNK; VOLUMAT PUMP, MFR UNK