MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH2000SC-10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a spinning spiros® closed male luer, red cap where it was reported that during an infusion of iv ara-c, checked blood return, attached chemo syringe to iv line, pushed chemo slowly then mom stated she had been sprayed by something.Checked iv line, there was fluid on the outside of the spiros and mom and patient were wet.The syringe started with 0.55ml and when i pushed chemo, there was 0.35ml left.Mom and patient were instructed to wash their hands with soap and water, pharmacy was called and looked at the chemo.A new syringe of ara-c was made with remaining dose of 0.35ml per doctor and pharmacy request.It was noted that the leak was on the outside of the spiros that was attached to the chemo syringe.Iv cytarabine was being pushed through the line.Chemo was sprayed directly onto the patient and mother on the arms and hands.No chemo was found on the floor or any other surface.Patient and mother were advised to wipe skin first to absorb any chemo on skin, then wash hands/ arms with warm soapy water.Syringe was prepared by central pharmacy and sent up to unit with spiros already attached.The chemo syringe was then attached to a chemo syringe tubing which was attached to the patient.All clamps were checked and unclamped.There is no blood loss or bleed back.The whole chemo line was discontinued, pharmacy was called, and per doctor direction, the remaining dose was remade, and given to patient.Any hole, cut, tears or any defect noted was not on initial inspection of chemo syringe.
Additional Manufacturer Narrative
One (1) used.List #ch2000s-c, spinning spiros® connected to one (1) used, b-d single use 1 ml syringe were returned for evaluation.As received chemo, iv cytarabine residuals were observed on the returned sample.No physical damage was observed.The spiros was tested as returned and a leak from inside the spiros was confirmed.Once the spiros was dissembled, it was observed the half seal was misalignment from the original location.Complaints of leak can be confirmed based on physical sample evaluation.The probable cause was an error during the assembly process.A lot history was reviewed and no commodities, discrepancies, anomalies, or nonconformance were identified, that might lead to the condition reported by the customer.
Additional Manufacturer Narrative
Medwatch information with report number (b)(4) received on 25jul2024.

• Brand Name: SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS
• 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: 19466494
• Report Number: 9617594-2024-00731
• Device Sequence Number: 3394418
• Product Code: FPA
• UDI-Device Identifier: 00840619042769
• UDI-Public: (01)00840619042769(17)280901(10)13766502
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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: CH2000SC-10
• Device Lot Number: 13766502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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: ARA-C ( CHEMOTHERAPY) MFR UNK.; B-D SINGLE USE 1 ML SYRINGE , MFR BD.
• Patient Sex: Unknown