MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED INTRAVENOUS ADMINISTRATION TUBING EXTENSION SET; UNKNOWN

Catalog Number UNKNOWN

Device Problems Failure to Infuse (2340); Mechanical Jam (2983)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/01/2023

Event Type  Death  

Manufacturer Narrative

It is unknown if the device will be returned for evaluation.Without the return of the sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.If additional pertinent information becomes available, a supplemental report will be submitted.

Event Description

The event occurred on an unspecified date and involved an unspecified product.The reporter stated that there was an incident in which the glass syringe jammed and couldn¿t be administered during resuscitation.The syringe was replaced.The patient died.The customer representative stated that the patient's death was not due to this issue.The customer further stated that the defective syringe appears to have plastic jammed in the luer lock ends.

Manufacturer Narrative

Device was received 12/18/23.One used unknown 10 ml glass syringe adrenaline (epinephrine) injection 1:10,000) 1mg in 10ml aurum pharmaceuticals was returned for evaluation.As received it was observed a piece of the microclave broken off inside the fluid path.No additional damage or anomalies were observed.The broken piece was taken off from the fluid path, and the id of the syringe was measured founding out of the specification from the compatible mating device.Complaint of no flow / can't prime / difficult to prime can be confirmed based on the physical sample evaluation.The use of glass tip/filled syringes are known to be dimensionally incompatible.Typically glass syringes have an internal diameter (id) of approximately 0.048¿ or lower.The directions for use states: the clave/microclave connector is compatible with luers with an internal diameter (id) between 0.062" and 0.110".Luers that have an id smaller than 0.062¿, such as the glass syringes, may cause damage to the clave spike or obstruct flow.The probable cause is typical due to access with an incompatible mating device during use.Two photos were shared by the customer, where a glass syringe is observed, no physical damage or anomalies are observed, the syringe was closed.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: UNSPECIFIED INTRAVENOUS ADMINISTRATION TUBING EXTENSION SET
• Type of Device: UNKNOWN
• 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: 16865001
• MDR Text Key: 314510181
• Report Number: 9617594-2023-00173
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UNK
• 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: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• 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: UNSPECIFIED GLASS SYRINGE, MFR UNK.
• Patient Outcome(s): Death