MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPIROS® CLOSED MALE LUER; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH2000
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.Udi is unknown as part and lot were not provided by the complainant.
Event or Problem Description
The report stated that they were experiencing leaking/disconnection issues with their spiros connectors.Most recently at their (b)(6).A spiros started leaking/unscrewing from a patient¿s tubing at a different location than before (where the device is not even supposed to unscrew).The nurse attached the spiros herself to the end of their iv tubing, as they have always done when they have an oncology drug that will run through the tubing.The nurse did hear the click that the spiros was connected properly to the tubing.The nurse started the drug and the patient called out saying something was leaking.On inspection, the nurse saw the leak was coming from between the attachment of the spiros and the bd max zero end cap.She stopped the drug, disconnected the spiros and dried the end cap off as she was instructed to do by the representative when they visited the department.The nurse reconnected the spiros to the max zero end cap and while doing that, the other end of the spiros became disconnected from the iv tubing.The customer asked the nurse if she was sure the spiros was connected to the tubing correctly and she said yes, it was spinning and not able to be unscrewed.So a little concerning that it did fall off the tubing end where it¿s supposed to be locked in.There was patient involvement, but there was no human harm reported.
Additional Manufacturer Narrative
The complaint of leaks on item ch2000 cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.The device history record review couldn't be performed due to the lot number for this complaint was unknown.

• Brand Name: SPIROS® CLOSED MALE LUER
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• 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: 19777342
• Report Number: 9617594-2024-00909
• Device Sequence Number: 8278831
• Product Code: ONB
• UDI-Device Identifier: 00840619023782
• UDI-Public: 00840619023782
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: CH2000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BD MAX ZERO END CAP; UNSPECIFIED DRUG , MFR UNK; UNSPECIFIED IV TUBING SET, MFR UNK
• Patient Sex: Unknown