MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED SPINNING SPIROS DEVICE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	UNKNOWN
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Anxiety (2328); Chemical Exposure (2570); Skin Inflammation/ Irritation (4545)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The complaint/event involved an unspecified spinning spiros® device.Leaks were reported at the port of an unspecified spinning spiro, non-return valve (=k zero adapter).The leakage was in the area where the connection valve was used.These were the following negative effects that were reported: 1.Unclear quantity of cytostatics actually infused.2.Skin irritation due to leaking cytostatics.3.Stressful situation for the patient (psychological component).4.Danger to third parties due to the uncontrolled release of cytostatic drugs.Product details are as follow: 1.K-zero adapter ref m79400849y, lot 32221354.2.Powerloc maxport needle: size 19 gx0.75, ref 0141975, lot asgxfc055.3.Spinning spiro (doc sid 4000 or doc sid 4000 r) 4.Elastomer pump.There was no report of any patient harm.
Additional Manufacturer Narrative
The complaint of leaks on spiros cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.The device history review (dhr) review couldn't be performed due to the lot number for this complaint was unknown.

• Brand Name: UNSPECIFIED SPINNING SPIROS DEVICE
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21905407
• Report Number: 9617594-2025-00832
• Device Sequence Number: 8728925
• Product Code: FPA
• UDI-Device Identifier: 00840619027568
• UDI-Public: 00840619027568
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: K-ZERO ADAPTER REFM79400849Y LOT 32221354, MFR UNK.; POWERLOCMAXPORTNDL: GX.75R#0141975LOTGXFC055.; UNSPECIFIED CYTOSTATIC DRUGS, MFR UNK.; UNSPECIFIED ELASTOMER PUMP, MFR UNK.
• Patient Sex: Unknown