MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ABG-PROVENT BLOOD COLLECTION; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	4598P-2
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the vented caps were leaking the blood sample out when they were getting the air out.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D9.Date returned to mfg: 18-nov-2024.Investigation summary: received for investigation twenty unopened packages product 4598p-2 lot # 6029284 and three packages of 4598p-2, lot # 6020214.The actual syringe and filter-pro device, used by the customer at the time of the complaint, was not returned for investigation.To evaluate the customer's reported claim, the needle assemblies were removed from the syringes and the filter-pros attached.The syringes were filled with a dye solution and while continuing to hold the syringe with luer uppermost, the filter-pro device was seated onto the syringe luer according to ifu (instructions for use) using a push and twist motion to fully seat the components together.The syringe was gently tapped to move all trapped air towards the luer of the syringe.The syringe and filter-pro assembly was placed into the test fixture and an axial force was applied to the plunger of the syringe, creating an internal pressure.While maintaining the pressure for 30 seconds, all aspects of the assembly were observed for signs of leakage between the components or for disengagement of the filter-pro device from the syringe luer.Leakage was observed with lot # 6029284.In-process, filter-pro devices are automatically assembled and glued from supplied components.Maintenance log review found no entries relevant to the reported problem on the date of manufacture.While the allegation was confirmed, it could not be stated with confidence whether the area was damaged, had a short fill or was not properly sealed.The exact problem source for the compromised filter-pro could not be identified.No further action will be conducted at this time.Complaint information will continue to be monitored for any new information or adverse trends and further actions taken accordingly.A device history record could not be completed as no lot number was received.

• Brand Name: PORTEX ABG-PROVENT BLOOD COLLECTION
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr; keene NH 03431
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20509424
• Report Number: 1217052-2024-00151
• Device Sequence Number: 15449454
• Product Code: JKA
• UDI-Device Identifier: 20351688040333
• UDI-Public: (01)20351688040333
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K952516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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: 4598P-2
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 01/06/2025
• 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