MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ABG-LINE DRAW 3ML; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	G1470J
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cap did not close.It seemed to come off without any resistance.There was no disinfection or sterilization, and no infectious disease occurred.There was no patient harm/adverse event reported.
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.
Additional Manufacturer Narrative
Received for investigation, twenty-one opened packages.Visual inspection revealed that the filter-pro devices were assembled to the syringes.No defects or anomalies were noted.They were checked all but one showed the luer fell within the gage limits.The gage limit showed the luer of the filter-pro housing to be smaller than the iso specification.To review the reported issue of a loose connection, the syringe and filter-pro devices were tested according to combo leak test.The syringes were filled with dyed water prior to re-assembling them to the filter-pros.The syringe and filter-pro assembly was placed into a test fixture whereby an axial force was applied (1.5-1.6 lbf) to the plunger of the syringe.Results: separation of the components was observed.When pressure was applied to the assembly the filter-pro "popped off" and became disconnected from the syringe.In this respect, the returned syringe samples and filter-pro devices did not function as intended.Therefore, the complaint was confirmed.

• Brand Name: PORTEX ABG-LINE DRAW 3ML
• 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: 21544023
• Report Number: 1217052-2025-00053
• Device Sequence Number: 12537514
• Product Code: JKA
• UDI-Device Identifier: 00351688060238
• UDI-Public: (01)00351688060238(17)250831(10)4336330
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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 Expiration Date: 08/31/2025
• Device Catalogue Number: G1470J
• Device Lot Number: 4336330
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2022
• 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