MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH2000S-PC
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it is yet to be received.
Event or Problem Description
The event involved a spinning spiros® closed male luer, purple cap and the customer reported that the healthcare professional (hcp) in the chemotherapy department observed a a significant flow/leak of product {phesgo medication) between the syringe and the spiros connector when passing it into a 10ml syringe on a syringe-driver.The customer reported about a 30 min delay in therapy as they had to redo the preparation of medication.There was patient involvement, but there was no harm reported as a consequence of this event.The medication did come into contact with the hcp but the staff was protected by gloves and blouse.The leak cleaned per facility protocol.
Additional Manufacturer Narrative
Two new in package ch2000s-pc, spinning spiros were returned for investigation of leakage.There was no visible damage or anomalies observed.No mating devices were returned to evaluate with the ch2000s-pc, spinning spiros.Subsequent leak testing found each of the ch2000s-pc spinning spiros met pressure leak testing expectations outlined in the product performance specification.The complaint was unable to be replicated or confirmed.Lot history review was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

• Brand Name: SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP
• Common Device Name: 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: 18253572
• Report Number: 9617594-2023-01060
• Device Sequence Number: 20630915
• Product Code: ONB
• UDI-Device Identifier: 00840619027568
• UDI-Public: (01)00840619027568(17)271201(10)13490828
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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: CH2000S-PC
• Device Lot Number: 13490828
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 12/03/2023
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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: PHESGO, MFR UNK
• Patient Sex: Unknown