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 Problems Disconnection (1171); Fluid/Blood Leak (1250); Separation Failure (2547)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

The event occurred on an unspecified date and involved a spinning spiros® closed male luer, red cap.It was reported that the basic tubing set connection into the spiros cap was leaking.The reporter stated that the tubing was made, caps were screwed in the past locking sound c-clamps were added to tubing after initial connection, all connections were aqua guarded.The patient called out to report fluid in the aqua guard.No leaking was noted during the day.The tubing appeared to be intact, the connection tightened and leaking stopped.The nurse came to assess the tubing, while double checking the connections to ensure there was no more leaking, and the other basic line into spiros easily disconnected.All connections were tightened and aqua guarded.The set-up was iv tubing to spiros and with maxzero nc.It was unknown on how long into infusion when the tubing separation/disconnection occurred.It is unknown what medication was infusing.There was patient involvement; harm was not reported as a consequence of this event.

Manufacturer Narrative

No product samples were returned for investigation, however, a photograph was returned showing the event description.There was nothing of note with the photo that was not captured in the written event description.The device history review was performed was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.

• 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: 18307910
• MDR Text Key: 330368891
• Report Number: 9617594-2023-01115
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026615
• UDI-Public: (01)00840619026615(17)280901(10)13763904
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• 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: 13763904
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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: MAXZERO¿ NEEDLE-FREE CONNECTOR, BD; UNSPECIFIED MEDICATION, MFR UNK