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 Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

No product samples were returned for investigation, however, a photograph and video were returned.The photo showed a connection between a spinning spiros and male spin luer that had tape over the connection interface.The video showed the successful connection and a disconnection of a male spin luer to the female luer of a spinning spiros.Evaluating the connection of the male luer to the female luer of the spinning spiros showed a secure connection being made, however, after the secure connection was made the user manipulated the male luer spin collar so as to purposefully loosen the spin collar from the threads of the female luer of the spinning spiros.Once the spin collar of the male luer was purposefully loosened and the thread to thread interface securing the luers together was removed the luer to luer connection was able to be pulled apart.There was no spinning spiros defect observed.The complaint that the spinning spiros caused a separation was unable to be confirmed.The device history report (dhr) for lot 13619409 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

Event Description

The event involved a spinning spiros® closed male luer, red cap where the customer reported an incident on chemotherapy spillage due to disconnect between male luer & infusion set after 12 hours of infusion.There was physical damage noted on the device and claims that it was on the connection area between the end of tail of spiros and the end of kabi infusion.The amount of spillage was unable to measure at the small area.Unable to provide the name of the chemo drug.There was unprotected chemotherapy exposure to the patient, health care worker or other personnel.The chemo spill was cleaned up per facility protocol and a spill kit was used.The set was replaced, and the therapy resumed without any problem.Sample video of the healthcare provider preparing the set where the clave was connected to the male luer part of the burette set and when trying to separate both ends, the clave just easily disconnects from the male luer part without unlocking the male luer lock was provided.There was patient involvement and no patient harm.

• 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: 18341014
• MDR Text Key: 331054585
• Report Number: 9617594-2023-01165
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026615
• UDI-Public: (01)00840619026615(17)280401(10)13619409
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K082806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2023

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: 13619409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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: UNCLEAR/UNSPECIFIED KABI INFUSION.; UNSPECIFIED CHEMOTHERAPY, MFR UNK.; UNSPECIFIED INFUSION SET, MFR UNK.