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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that a spinning spiros® closed male luer, purple cap generated a leak during patient use.The reporter stated, ¿leaking between the spiros and the bd maxplus." the sample is available.There was patient involvement, no delay in therapy, no harm as a result of the reported event.There was no death or serious deterioration as a result of the event.
Additional Manufacturer Narrative
Investigation summary: received one (1) used ch2000s-pc spinning spiros connected to one (1) used bd maxplus for inspection.No defects or anomalies noted.The spiros was leak tested per product specifications.There was no leakage.The reported complaint was unable to be replicated or confirmed.The dhr for lot 13490824 was reviewed and no relevant non conformities were found that would have led to the reported complaint.

• 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: 19640499
• Report Number: 9617594-2024-00853
• Device Sequence Number: 12612391
• Product Code: FPA
• UDI-Device Identifier: 00840619027568
• UDI-Public: (01)00840619027568(17)271201(10)13490824
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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: 13490824
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 06/29/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2022
• 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: BD MAXPLUS; UNSPECIFIED FLUID, UNK MFR
• Patient Sex: Unknown