MAUDE Adverse Event Report: SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	CH2000SC-10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for further evaluation.
Event or Problem Description
A user facility mandatory medwatch report was received on 17-sep-2021 stating that medication came from the pharmacy with tubing having a poor connection to the spiros device being used during the event.This caused the medication to leak out from it when hooked up to the iv pump.Vidaza leaked through the tubing site that was connected to the spiro.There were no injuries reported.No additional information is available at this time.
Additional Manufacturer Narrative
The device history review for the reported lot was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

• Brand Name: SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12598988
• Report Number: 9617594-2021-00273
• Device Sequence Number: 3193497
• Product Code: FPA
• UDI-Device Identifier: 00840619042769
• UDI-Public: (01)00840619042769(17)260601(10)5443491
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K070532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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 Expiration Date: 06/01/2026
• Device Model Number: CH2000SC-10
• Device Catalogue Number: CH2000SC-10
• Device Lot Number: 5443491
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 10/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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: BAXTER SET 2C8537 LOT (10) R21B24019; UNSPECIFIED CHEMOTHERAPY, UNK MFR