MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD CO

Model Number	4041E
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that at the end of therapy with a smiths medical sharps safety|portex abs linedraw dry heparin, it was noted that the plunger fell out and the syringe was emptied after blood test.No adverse effects were reported.

• Brand Name: PORTEX
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD CO
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• MDR Report Key: 12506774
• Report Number: 3012307300-2021-09495
• Device Sequence Number: 12096789
• Product Code: JKA
• UDI-Device Identifier: 20351688039177
• UDI-Public: 20351688039177
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K952516
• Number of Events Summarized: 1
• Summary Report (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): 09/21/2021

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: No Information
• Device Expiration Date: 09/30/2023
• Device Model Number: 4041E
• Device Catalogue Number: 4041E
• Device Lot Number: 4099833
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1