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	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product samples were returned for investigation; however, a series of photographs were returned showing the involved ch2000s-pc product assembly attached to a syringe at the female luer end and an unidentified subcutaneous needle hub at the male luer end.The reported difficulty infusing could not be verified or confirmed from the photos provided, however, a fluid leak was observed internal to the ch2000s-pc product assembly.The device history review (dhr) for lot 12718032 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.
Event or Problem Description
The event involved a spinning spiros® closed male luer, purple cap.The reporter stated a spiros closed male connector was connected to a 5ml terumo syringe; the customer explained that they were unable to push the dose of azacitidine out of the syringe through the attachment (spiros closed male connector (ch2000s-pc).The patient was in the seat, and the clinician was attempting to administer the fluid, however it was not priming.There was a delay in therapy since the clinician had to discard and remake the clinical procedural pack for administration.The solution/medication involving azacitidine powder form chemotherapy drug, with added water for injection.There was approximately 1 hour delay.There was patient involvement, however no report of patient harm.This report captures one of two occurrences.

• 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: 18398860
• Report Number: 9617594-2023-01194
• Device Sequence Number: 2804865
• Product Code: FPA
• UDI-Device Identifier: 00840619027568
• UDI-Public: (01)00840619027568(17)271101(10)12718032
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: CH2000S-PC
• Device Lot Number: 12718032
• 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: 12/01/2023
• Initial Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2023
• 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: 5ML SYRINGE.; AZACITIDINE POWDER CHEMOTHERAPY DRUG, UNK MFR.
• Patient Sex: Unknown