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
Additional Manufacturer Narrative
Five devices were received for evaluation.A functional test was performed and the reported issue was duplicated.The probable cause of the reported issue was that the silicone material may have migrated past the luer and when the filter-pro was attached, seeped onto the housing luer and thus resulted in a loose connection.The service history review had no indication that the complaint was related to a service of the device within the review period.
Additional Manufacturer Narrative
Five devices were received for evaluation.A functional test was performed and the reported issue was duplicated.The probable cause of the reported issue was that the silicone material may have migrated past the luer and when the filter-pro was attached, seeped onto the housing luer and thus resulted in a loose connection.The service history review had no indication that the complaint was related to a service of the device within the review period.
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 cap did not close, and it came off quickly.According to the user facility, there were no infectious disease reported due to the result of the event.There were no patient harm or adverse events reported.

• 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: 21622081
• Report Number: 1217052-2025-00062
• Device Sequence Number: 12460196
• Product Code: JKA
• UDI-Device Identifier: 00351688060238
• UDI-Public: (01)00351688060238(17)270331(10)6021196
• 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,Followup
• Report Date (Section B): 05/30/2025

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: G1470J
• Device Lot Number: 6021196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 05/01/2025; 05/01/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 05/30/2025; 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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