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 Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The defective syringe and component used were not received for investigation; however, an unused sample of the same lot was received to perform an investigation.As the defective syringe and component used were not returned an assessment for cause could not be made.Inspection of the unused returned components of the returned kits did not find any visible signs of any defects.The returned syringe was tested for potential leakage and no leakage was observed.Based on the syringe returned, this complaint cannot be confirmed.A device history record (dhr) 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# (b)(4).
Event or Problem Description
It was reported that while attempting to put the cap on the blood sample and push the sample to the tip for blood to reach heparin cap, the blood squirted out of the cap and onto the employee.The plunger on the syringes also came out very easy.No injury was reported.

• 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: 15334100
• Report Number: 3012307300-2022-17145
• Device Sequence Number: 6486204
• Product Code: JKA
• UDI-Device Identifier: 20351688061420
• UDI-Public: 20351688061420
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/01/2022

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: 05/11/2023
• Device Model Number: 4041LH
• Device Catalogue Number: 4041LH
• Device Lot Number: 3996707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2020
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown