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

Catalog Number	G1732
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.The actual syringe and filter-pro device, used by the customer at the time of the complaint, was not returned for evaluation.120 returned samples (taken from all boxes) were function tested.Thirty returned samples did not pass the leak test.Within 10 seconds liquid was escaping through one edge of the filter-pro.Therefore, functional testing confirmed the reported problem.Visual inspection of the returned samples did not reveal any defects or anomalies.The root cause could not be established.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
Event or Problem Description
It was reported that the device had issues with blood leaking through and around the portex filter pro due to issues with the seals.There was no patient involvement, and no patient harm reported.

• Brand Name: PORTEX FILTER PRO
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20145145
• Report Number: 1217052-2024-00098
• Device Sequence Number: 4247855
• Product Code: JKA
• UDI-Device Identifier: 10351688070562
• UDI-Public: (01)10351688070562(17)290306(10)4466990
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K911638
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/05/2024

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 Catalogue Number: G1732
• Device Lot Number: 4466990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• 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