MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PROXIMALE - 28 CM (11") SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VA; STOPCOCK, I.V. SET

Catalog Number 011-AM6118

Device Problems Disconnection (1171); Infusion or Flow Problem (2964)

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

Event Date 12/22/2021

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation.It has not been received.

Event Description

The event involved a proximal - 28 cm (11") smallbore ext set w/6-port nanoclave® manifold, check valve, nanoclave® (red rings), rotating luer that occurred in the surgical intensive care unit and the customer reported during infusion the safety cap detached (pulled out?) and there was air intake.The customer stated the patient was in the chair and the device was found detached on the pump side.There was no clinical consequence and the line was clamped.The proximal line reflux was ok, no air.There was no hdm (history of the disease) or respiratory instability noted.The patient was stable, no change related to the incident.No need for medical intervention.The device was replaced and the therapy completed.The customer stated it was a simple hydration leak so no special cleaning needed and no report of blood loss.There was patient involvement, however, no report of harm.

Manufacturer Narrative

Received one used list #011-am6118, proximale - 28 cm (11") smallbore ext set w/6-port nanoclave® manifold, check valve, nanoclave® (red rings), rotating luer; lot #unknown on march 7, 2022 for evaluation.A used 011-am6118 smallbore extension set w/6-port nanoclave manifold was returned for investigation with the proximal nanoclave body separated from the spike portion.Close examination showed that the spike was necked typical of access with an incompatible mating device.The 011-am6118 snap fitment design interfaces were measured and found to be within specification.The probable cause of the spike damage and body separation from the spike is typical of access with an incompatible mating device and inadvertent bending forces applied during use.The directions for use (dfu) states: needlefree connectors are compatible with iso male luers having an internal diameter between 0.062 inches (1.58 mm) and 0.110 inches (2.8 mm).A lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: PROXIMALE - 28 CM (11") SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VA
• 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: 13533352
• MDR Text Key: 294658711
• Report Number: 9617594-2022-00020
• 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: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-AM6118
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• 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: INFUSION PUMP, FRESENIUS, MODULE MVP MS IEC; UNSPECIFIED FLUIDS, MFR UNK
• Patient Sex: Male