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

Model Number 011-MC100

Device Problem Failure to Deliver (2338)

Patient Problem Cardiac Arrest (1762)

Event Date 07/22/2022

Event Type  Death  

Event Description

The event occurred involved a microclave® clear connector.The customer reported that during a patient cardiac arrest, a link adrenaline minijet was unable to be administered through the icu medical iv connector.It was identified that the glass syringes used for adrenaline and atropine emergency pre-made syringes did not appear to open the valve in the connector to allow the drug to be administered.There was no issue using the icu medical bung with the standard bd luer lock syringe when the customer investigated this issue.The event occurred during priming.Please note that there were 2 lot numbers that were reported to be associated with this event; 2 microclave clear connectors were opened and used.The reported clinical events were life-threatening and intervention was required to attempt to preclude permanent impairment of a body function or permanent damage to a body structure.Icu medical was made aware on july 27 2022 that the patient did not survive the event.

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 information becomes available a supplemental report will be submitted.Lot 5884953 expiration date 03/1/2027 manufactured date 03/1/2022.Lot 5620237 expiration date 09/1/2026 manufactured date 10/12/2021.

Manufacturer Narrative

The complaint of no flow could not be confirmed.No product samples, pictures, or videos were received for investigation.The customer was connected and no further samples, sister samples or information could be provided.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history record (dhr) was reviewed and no non conformities were found that would have led to the reported complaint.H4 - device mfg date: 3/1/2022 updated/corrected information can be found in h1 and h6.

• 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
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 15259343
• MDR Text Key: 298230102
• Report Number: 9617594-2022-00241
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619042509
• UDI-Public: (01)00840619042509(17)270301(10)5884953
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K970855
• 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: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 011-MC100
• Device Catalogue Number: 011-MC100
• Device Lot Number: 5884953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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: ADRENALINE EMERGENCY PREMADE SYRINGES, MFR UNK; ATROPINE EMERGENCY PREMADE SYRINGES; BD LUER LOCK SYRINGE; LINK ADRENALINE MINJET, MFR UNK
• Patient Outcome(s): Death; Life Threatening