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

Catalog Number	CH2000S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
It was reported that a spinning spiros¿, closed male luer was found to have become detached during patient use.The problem was: that some spiros product code: ch2000s seemed to be detaching from their 50ml syringes when utilized for intravesical treatments.There was no patient harm reported.
Additional Manufacturer Narrative
(b)(4) new samples #(b)(4) were returned for evaluation, as received no physical damage or anomalies were observed.Three (3) new list# unknown bd 50ml syringes were returned as mating devices.The fit of a spiros with a bd syringe was tested.There was no difficulty attaching the spiros and it stayed firmly attached.(b)(4) of the spiros were torque test activated, tested for residual torque, and confirmed to meet the product specification.All the spiros present a good shear tab activation and no damage on the splines.The male luers on the spiros and returned syringes were confirmed to comply with iso design expectations.Complaint of spiros detaching cannot be confirmed or replicated.A device history review (dhr) lot and relevant commodities were reviewed, and the following discrepancy was identified: discrepancy: "on (b)(6) 2024 a1 shift press b4 item r1-8245 (body,0.075, spiros, hardstop) cavity a15 was found to have came unblocked.It was blocked due to damage on the luer.075 dimension after bracketing totes 4, 5 were affected.Qe 6.3.2024 upon review of the samples it was found that these are short shots.See photos" "on (b)(6) 2024 a1 shift qa found on press# d1, part# r1-15956 (post, female luer, spiros) lot# 13996004, mold# 4326, on 2nd visual cavs- f1, f2, f4 had short shots on the side tab.Per drawing r1-15956-mc section 2c not acceptable.After bracketing totes 10,11,12, are good and tote 13 was affected.".

• Brand Name: SPINNING 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: 21530816
• Report Number: 9617594-2025-00405
• Device Sequence Number: 9712626
• Product Code: ONB
• UDI-Device Identifier: 00840619033903
• UDI-Public: (01)00840619033903(17)290801(10)14096282
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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
• Device Lot Number: 14096282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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
• Patient Sex: Unknown