MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX SINGLE LINE PRESSURE MONITORING KIT; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	MX9604A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when installing the invasive blood pressure transducer, saline solution leakage occurred in the valve of the washing system.The event occurred in the adult icu, and the procedure that was being performed at the time was catheterization/angioplasty.The customer informed that the event was observed in pre-test, before use, but the transducer was already installed in the patient.
Additional Manufacturer Narrative
E1 - initial reporter phone: ext (b)(6).One opened sample unused device sample out of its original package was received.The complaint was confirmed through the analysis of the returned device, the reported condition is related to a leak defect caused from manufacturing.Awareness for the failure mode was given to personnel who perform the assembly process.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: MEDEX SINGLE LINE PRESSURE MONITORING KIT
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19906917
• Report Number: 9616567-2024-00109
• Device Sequence Number: 8731675
• Product Code: DRS
• UDI-Device Identifier: 10351688502933
• UDI-Public: (01)10351688502933(17)241018(10)4210972
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K820355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2024

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 Expiration Date: 10/18/2024
• Device Catalogue Number: MX9604A
• Device Lot Number: 4210972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• 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
• Patient Sex: Unknown