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

Catalog Number	UNKNOWN
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Anxiety (2328); Skin Inflammation/ Irritation (4545); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).It is unknown if the device is available for evaluation.The device has been requested to be returned; however, it has not been received.Without the returned device, a probable cause is unable to be determined.The investigation is pending.
Event or Problem Description
The event involved an unspecified spinning spiros where it was reported that it leaks at port, spinning spiro, non-return valve (=k zero adapter) in connection with elastomer pump.The problem was the fluid leakage in the area of the connection valves used.These are the following negative effects: 1.Unclear quantity of cytostatic actually infused.2.Skin irritation due to leaking cytostatic.3.Stressful situation for the patient (psychological component).4.Danger to third parties due to the uncontrolled release of cytostatic drugs.There was patient involvement.
Additional Manufacturer Narrative
The reported complaint of a leak could not be confirmed.Without the return of the sample or a photo/video, a comprehensive review cannot be performed and a probable cause cannot be determined.No lot or item number was provided for a dhr review.Corrected information can be found in concomitant products, e1 - initial reporter phone, h6 health effect - clinical codes and h6 health effect - impact code.

• Brand Name: UNSPECIFIED SPINNING SPIROS
• 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: 21773394
• Report Number: 9617594-2025-00652
• Device Sequence Number: 8079517
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 06/02/2025
• 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: CYTOSTATIC DRUG, MFR UNK.; ELASTOMER PUMP, MFR UNK.; UNSPECIFIED CYTOTOXIC DRUG, MFR UNK.
• Patient Sex: Unknown