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

Model Number 96000

Device Problems Product Quality Problem (1506); Defective Device (2588)

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

Event Date 01/01/2020

Event Type  malfunction  

Event Description

It was reported that the plastic frequently breaks off.The broken piece is then in the blue cap.Not believed to have occurred due to force used.No patient injury reported.

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.The returned sample was received in used condition without its original packaging.Visual testing was performed.Visual inspection found the luer of the saf-t holder product broken.The most probable root causes are: the crack luer failure is attributable to an exposure of the product to alcohol in combination with excessive force and the luers come weak from supplier.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• Brand Name: JELCO SAF-T HOLDER DEVICES
• 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: 15328347
• MDR Text Key: 305385676
• Report Number: 3012307300-2022-17050
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• 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: 3881692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1