MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX TUBES BLUSELECT SUCTIONAID; BAG, RESERVOIR

Catalog Number	101/870/070CZ
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number 3011237704-2025-00032-00.The date of that submission was 25-feb-2025.Investigation summary: one used decontaminated sample (b)(6) 7.5mm deht blu suctionaid sub-assy was returned for investigation.Customer is claiming that the blue suction connector is cracked.Under visual inspection suction connector seems to be without any defect.A luer slip syringe was inserted into the connector and crack was observed.Affected part 10013213-001 suction line sub-assembly bluselect bulk packaged was manufactured by icu medical tijuana.This defect can be caused by applying excessive force when connecting the syringe or during the connection of the suction device, the root cause cannot be associated with the manufacturing process.No signal of confirmed customer complaints was identified in relation with this issue.A device history record could not be completed as no lot number was received.
Event or Problem Description
It was reported that the suction line cracked during use on the patient.Someone became aware of the issue when staff noticed patient bleeding out into the bed.The product was not reprocessed or re-sterilized prior to use.The product was not contaminated nor contained a biohazard or chemotherapeutic agent.There was delay in therapy, but no patient harm/adverse event reported.

• Brand Name: PORTEX TUBES BLUSELECT SUCTIONAID
• Common Device Name: BAG, RESERVOIR
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21950778
• Report Number: 3012307300-2025-05172
• Device Sequence Number: 20969396
• Product Code: BTC
• UDI-Device Identifier: 15019517076202
• UDI-Public: (01)15019517076202
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2025

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: 101/870/070CZ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 05/02/2025
• 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
• Patient Sex: Unknown