MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30 CM (12") ARBRE UNIVERSEL AMBRE AVEC 2 ACCES LUER AVEC VALVE AR ET BOUCHON; BASIC INTRAVENOUS ADMINISTRATION SET, NONINVASIVE

Catalog Number 011-H3248

Device Problem Material Separation (1562)

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

Event Date 12/05/2023

Event Type  malfunction  

Event Description

The event involved a 30 cm (12") arbre universel ambre avec 2 acces luer avec valve ar et bouchon.It was reported disconnection of the valve from its tubing during priming.Additional it was stated that the patient was connected at the device at the time of the event , with no one being harmed, no adverse event , the health condition of the patient was stable, no blood loss and that there was a delay in therapy of 20 minutes for the tubing change and re-priming , with the therapy being successful.

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Manufacturer Narrative

Received one (1) used.List #011-h3248, 30 cm (12") arbre universel ambre avec 2 acces luer avec valve ar et bouchon; lot #13576129.A back check valve was observed to be separated from the tubing.No other damages or anomalies were observed.The reported complaint of separation could be confirmed.The back check valve was disconnected upon arrival.The probable cause of the separation is from insufficient solvent coverage during manual assembly.The lot history was viewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 30 CM (12") ARBRE UNIVERSEL AMBRE AVEC 2 ACCES LUER AVEC VALVE AR ET BOUCHON
• Type of Device: BASIC INTRAVENOUS ADMINISTRATION SET, NONINVASIVE
• 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 covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18451372
• MDR Text Key: 332738642
• Report Number: 9617594-2024-00011
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3248
• Device Lot Number: 13576129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2023
• 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