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

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that while attempting to put the cap on a 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.

Manufacturer Narrative

No product sample was received; therefore, visual, and functional testing could not be performed.A device history record (dhr) review was performed, and no issues were noted during manufacture.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).

• Brand Name: PORTEX LINE DRAW ARTERIAL BLOOD SAMPLING KITS
• Type of Device: 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: 15334102
• MDR Text Key: 305288886
• Report Number: 3012307300-2022-17146
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 20351688061420
• UDI-Public: 20351688061420
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2023
• Device Model Number: 4041LH
• Device Catalogue Number: 4041LH
• Device Lot Number: 3992999
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1