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)

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

Event Date 11/10/2023

Event Type  malfunction  

Event Description

The complaint/event involved a spinning spiros® closed male luer, red cap.It was reported that a new spiros cap disconnected from the intravenous (iv) tubing and then chemotherapy dripped into the valgaurd (surrounding the patient line) during a continuous methotrexate infusion through the male patient's port.The set-up was iv tubing to spiros and with maxzero nc.It was less than an hour into infusion when the tubing separation/disconnection occurred.No chemo was spilled outside of the valguard.The cap was changed, and patient sheets were changed.No issues arose from the event.Although patient harm was not reported, some chemotherapy was lost as a result of the device complaint.

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 record 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: 18273554
• MDR Text Key: 329826375
• Report Number: 9617594-2023-01077
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2023

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: 13763904
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/06/2023
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MAXZERO NC, MFR UNK; METHOTREXATE, MFR UNK; UNSPECIFIED IV TUBING/LINE, MFR UNK; UNSPECIFIED PATIENT PORT, MFR UNK; VALGAURD, MFR UNK
• Patient Age: 10 YR
• Patient Sex: Male