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	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A picture was returned showing a spiros attached to unknown mating devices was retuned.The resolution of the picture is not high enough to identify if there are any anomalies at the spiros connections.The complaint of ' spiros being pushed out by positive pressure picc bung' cannot be confirmed based on the returned images.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A lot history review could not be conducted because no lot number(s) was/were identified.
Additional Manufacturer Narrative
The device is not available for evaluation; however, a photo was provided.Investigation is pending.
Event or Problem Description
The event involved a spinning spiros® closed male luer, purple cap where it was reported when the registered nurse (rn) connected spiros to maxplus, there were two episodes of spiros being pushed out by positive pressure peripherally inserted central catheter (picc) bung.In one instance you could actually see the spiros being rotated and pushed out despite how hard it was placed back.The drug involved was paclitaxel.There was patient involvement, and a delay in therapy but no patient harm as a result of the reported event.This report captures two occurrences.

• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19564088
• Report Number: 9617594-2024-00779
• Device Sequence Number: 17916567
• Product Code: ONB
• UDI-Device Identifier: 00840619027568
• UDI-Public: 00840619027568
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/25/2024

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: 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: 05/20/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: MAXPLUS, UNK MFR.; PACLITAXEL, UNK MFR.; PERIPHERALLY INSERTED CENTRAL CATHETER, UNK MFR.
• Patient Sex: Unknown