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

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

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 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
• 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: 18398860
• MDR Text Key: 331737759
• Report Number: 9617594-2023-01194
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619027568
• UDI-Public: (01)00840619027568(17)271101(10)12718032
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CH2000S-PC
• Device Lot Number: 12718032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2023
• 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: 5ML SYRINGE.; AZACITIDINE POWDER CHEMOTHERAPY DRUG, UNK MFR.