MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ABS PRO-VENT ARTERIAL BLOOD SAMPLING; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	G1463J
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "blood leaks from syringe".There was no disinfection or sterilization, and no infectious disease occurred.This occurred during use.There was patient involvement and no patient harm/adverse event reported.
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.
Additional Manufacturer Narrative
Evaluation codes: updated.One device sample was received.Visual inspection showed the luer slip syringe was partially broken on the shoulder.The condition of the sample was such that it was not possible to conduct a leak test.The noted damage resulted in a hole being present, confirming that leakage would most likely occur.Based on the results of this investigation the complaint was confirmed.The root cause was not established, and a quality alert has been issued to the production floor to heighten awareness towards this potential issue.Complaint information will continue to be monitored for any new information and future 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 PRO-VENT ARTERIAL BLOOD SAMPLING
• 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: 19278788
• Report Number: 1217052-2024-00013
• Device Sequence Number: 6358393
• Product Code: JKA
• UDI-Device Identifier: 00351688060177
• UDI-Public: (01)00351688060177(17)261113(10)4444813
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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: G1463J
• Device Lot Number: 4444813
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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