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

Catalog Number 011-MC100RR

Device Problem Air/Gas in Device (4062)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

The complaint/event occurred on an unspecified date and involved a microclave¿ clear connector w/red ring.The reporter stated that air bubbles were present in the connector when flow of an unspecified fluid was initiated.The defective unit was discarded as medical waste.There was no report of human harm associated with the complaint/event.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Event Description

The customer provided additional information indicating that the facility used the item for a wide variety of operations.Air bubbles entering the cap were observed.The event was noticed immediately after injecting the substance.The item was replaced with another one.The faulty item was tested at the facility and air bubbles were noticed.

Manufacturer Narrative

Two photos showing the list # 011-mc100rr in the sealed packaging were provided by the customer.No damages or anomalies noted.The complaint could not be confirmed by investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history record was reviewed and no non-conformities were identified that would have led to the reported complaint.Additional information can be found in b5.

• Brand Name: MICROCLAVE¿ CLEAR CONNECTOR W/RED RING
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18727748
• MDR Text Key: 336331123
• Report Number: 9617594-2024-00162
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 04/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC100RR
• Device Lot Number: 13752737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• 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 INFUSATE/SOLUTIUON, MFR UNK