MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MICROCLAVE CLEAR CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 011-MC100

Device Problems Device-Device Incompatibility (2919); No Flow (2991)

Patient Problem Cardiac Arrest (1762)

Event Date 08/10/2020

Event Type  Injury  

Manufacturer Narrative

The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.If additional information becomes available a supplemental report will be submitted.A device history review (dhr) could not be completed due to the unknown lot number.

Event Description

The customer reported a patient was in cardiac arrest and they were trying to attach an emergency glass syringe to the microclave.The customer stated, ¿during a cardiac arrest on pediatric icu the above connectors did not allow injection of the emergency drugs and an alternative product was used to administer adrenaline¿.The customer reported that the injury was serious and there was a delay in resuscitation.Additionally, the customer stated they looked it up and now know that none of the microclave nfcs are compatible with prefilled glass syringes.The customer reported 5 microclaves were involved in the event.This report reflects the fifth of 5 devices.

Manufacturer Narrative

No product samples were returned for investigation, however, a graphic was returned showing steps for using emergency glass syringes when using microclave connectors.An attempt was made by icu medical to have the facility provide sister samples for investigation but the customer responded that no samples were unable to be provided.No device history review (dhr) lot review was conducted because no lot number(s) was/were identified.Although the exact probable causes are unknown, use of glass tip/filled syringes are known to be dimensionally incompatible.Typically glass syringes have an internal diameter (id) of approximately 0.048¿.The clave/microclave requires a minimum of 0.062¿ id from the mating luer to accommodate the clave internal cannula.Luers that have an id smaller than 0.062¿, such as the glass syringes, may cause damage to the clave spike or obstruct flow.

• Brand Name: MICROCLAVE CLEAR CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 10482045
• MDR Text Key: 205277408
• Report Number: 9617594-2020-00364
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K970855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EMERGENCY GLASS SYRINGE, MFG UNK; IV DEVICE, MFR UNK; EMERGENCY GLASS SYRINGE, MFG UNK; IV DEVICE, MFR UNK
• Patient Outcome(s): Life Threatening