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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED MICROCLAVE; SET, ADMINISTRATION, INTRAVASCULAR
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED MICROCLAVE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problem No Flow (2991)
Patient Problem Cardiac Arrest (1762)
Event Date 11/08/2020
Event Type  malfunction  
Manufacturer Narrative
No product samples, videos, or photographs were returned for investigation.A device history review (dhr) lot review could not be conducted because no lot number(s) was/were identified.The reported complaint cannot be confirmed based on the information that has been provided.Reporter phone: (b)(6).
 
Event Description
The event involved an unspecified microclave that the customer reported a delayed administration of adrenaline (epinephrine) injection 1:10,000 pre-filled syringe during a periarrest situation due to a faulty syringe tip/adapter.The customer stated on closer inspection of the syringe after the incident, it was noted that the adrenaline syringe tip/adapter was blocked with the septum of the needle free connector (microclave).The patient had a deltaven 18 g cannula.The septum of the microclave became lodged in the glass syringe when the syringe was docked into the microclave.Originally, there was an unspecified minor injury reported and the details was unclear at the time because it was reported as a drug error with the syringe being blamed.An update was provided stating there was a delay in giving the adrenaline and one patient died but not as a result of this.When asked what the medical intervention was to the patient, the customer answered, a new cannula, bd profsafety, was inserted to administer the adrenaline and there was a short delay in the therapy while a new cannula was inserted.The customer stated this was not thought that this harmed the patient.This is the first of two incidents.
 
Manufacturer Narrative
No product samples, videos, or photographs were returned for investigation.A device history review (dhr) lot review could not be 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.
 
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Brand Name
UNSPECIFIED MICROCLAVE
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 Key11605068
MDR Text Key245619213
Report Number9617594-2021-00109
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00(01)(17)(10)
UDI-Public(01)(17)(10)
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received04/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ADRENALINE 1:10,000 PREFILLED SYRINGE, AURUM MFR; DELTAVAN 18G CANNULA, DELTAVEN MFR; PROSAFETY CANNULA, BECTON DICKINSON MFR
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