MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ABG-PROVENT BLOOD SAMPLING KIT; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	G1460J
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.E1 - initial reporter email and last name unknown.One unopened device was returned for evaluation.Visual inspection of the returned sample showed skiving to the syringe barrel shoulder.The noted damage resulted in a hole being present, thus complaint confirmation.Functional testing was not conducted as it was evident the hole on the barrel would cause leakage to occur.A root cause for the issue could not be determined.The dhr information for this lot, indicated that the product met established acceptance requirements.
Event or Problem Description
It was reported that the device was broken when checked before use.Device evaluation noted a leakage issue.There was no patient involvement, and no patient harm reported.

• Brand Name: PORTEX ABG-PROVENT BLOOD SAMPLING KIT
• 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: 19967600
• Report Number: 1217052-2024-00074
• Device Sequence Number: 21074440
• Product Code: JKA
• UDI-Device Identifier: 00351688060146
• UDI-Public: (01)00351688060146(17)261113(10)4445731
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2024

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: G1460J
• Device Lot Number: 4445731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• 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