MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO SAF-T HOLDER MULTI SAMPLE LUER A; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COL

Model Number 96000

Device Problem Use of Device Problem (1670)

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

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found no discrepancies in the returned sample.Functional testing performed using a syringe for introducing water in the received sample in order to verify any leakage.No discrepancies were found in the retuned samples by customer.Device passed all functional testing.No problem found.Root cause cannot be determined as the sample was successfully tested and no discrepancies were detected.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that blood drawing procedure is interrupted when using the device to draw blood from an iv catheter through an extension set.No patient injury was reported.

• Brand Name: JELCO SAF-T HOLDER MULTI SAMPLE LUER A
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COL
• 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: 15362795
• MDR Text Key: 305273465
• Report Number: 3012307300-2022-17962
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 20351688062953
• UDI-Public: 20351688062953
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96000
• Device Catalogue Number: 96000
• Device Lot Number: 3889167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1