MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS® CLOSED MALE LUER, RED CAP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number CH2000S-C

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/23/2023

Event Type  malfunction  

Event Description

The event involved spinning spiros® closed male luer, red cap where it was reported that when the device was advanced into the vessel, when pulled back to adjust positioning, the device was detached.Device was able to be removed with no harm.

Manufacturer Narrative

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

Manufacturer Narrative

One (1) used sample #ch2000s-c, spinning spiros was returned for evaluation.As received the spinning mechanics was correctly activated and no spline damage or shear tab anomalies were confirmed.The residual torque was found within specification.No mating device was returned for evaluation.The iso female luer meet the product design specifications.Complaint of separation can be confirmed based that the sample being returned with the spin feature activated and disconnected from the mating device.The probable cause of the separation is unknown.

• Brand Name: SPINNING SPIROS® CLOSED MALE LUER, RED CAP
• 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: 18592678
• MDR Text Key: 334725682
• Report Number: 9617594-2024-00060
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

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: CH2000S-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2023
• Initial Date FDA Received: 01/27/2024
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 03/11/2024
• 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