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

Model Number	4041LH
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the syringe expressed air and blood leaked from the plunger end of barrel.No patient injury reported.
Additional Manufacturer Narrative
Received for investigation one 1ml syringe decontaminated, in a bag with no other components or packaging present.Review of photo from customer shows blood, spread from the top portion of the barrel to the luer tip of the syringe.This amount of blood would not likely to be present if there was leakage past the plunger tip.The 1 ml syringe was tested colored water was added for better visual.Syringe functioned as expected no leakage was observed.Based on the provided sample, the event reported by the customer problem could not be confirmed.No further action will be conducted at this moment.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.Device history records review found no discrepancies or anomalies relevant to the complaint.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

• Brand Name: PORTEX LINE DRAW ARTERIAL BLOOD SAMPLING KITS
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD CO
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15353878
• Report Number: 3012307300-2022-17684
• Device Sequence Number: 5863381
• Product Code: JKA
• UDI-Device Identifier: 20351688061420
• UDI-Public: 20351688061420
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K952516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2022

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: 05/27/2023
• Device Model Number: 4041LH
• Device Catalogue Number: 4041LH
• Device Lot Number: 3996709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 09/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown