MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ABS LINEDRAW DRY HEPARIN; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	G1469J
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: month and year of event have been provided; day is unknown.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 there was "blood exposure." the event occurred in (b)(6) 2024.The sample was available for investigation.The event occurred during infusion at the facility.There was a patient involvement, but no harm/adverse event reported.There was no disinfection or sterilization, and no infectious disease occurred.
Additional Manufacturer Narrative
H3 and h6.Codes: updated.Device evaluation: received for investigation: an opened box containing twenty-one sealed packages of product 3ml line-draw syringe g1469j lot # 4467041.Pictures were also provided.The samples were visually inspected within the package, and all had the filter-pro attached to the syringe.No defects or anomalies were noted.The samples were leak tested, and four samples failed.Leakage was observed from the filter-pro, confirming the complaint.The root cause of the leaks was unknown.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: PORTEX ABS LINEDRAW DRY HEPARIN
• 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: 20558674
• Report Number: 1217052-2024-00157
• Device Sequence Number: 8866130
• Product Code: JKA
• UDI-Device Identifier: 00351688060238
• UDI-Public: (01)00351688060238(17)270306(10)4467041
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K952516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: G1469J
• Device Lot Number: 4467041
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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