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 Disconnection (1171)

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

Event Date 11/07/2023

Event Type  malfunction  

Event Description

The event involved a spinning spiros® closed male luer, red cap.It was reported that the registered nurse (rn) connected a new admit to new tubing with spiros on the end.Rn twisted spiros onto cap tightly and it disconnected itself.The tubing would not stay on, and they had to change to new spiros.It occurred during initial connection not during infusion.The set-up was iv tubing to spiros and with maxzero nc.The patient is a 15-year-old white female.There was a patient involved and no patient harm.

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 report (dhr) 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: 18310371
• MDR Text Key: 330279789
• Report Number: 9617594-2023-01125
• 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: K173477
• 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
• Report Date: 12/12/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/12/2023
• 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: UNSPECIFIED TUBING, MFR UNK.
• Patient Age: 15 YR
• Patient Sex: Female