MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO VENIPUNCTURE NEEDLE-PRO SAFETY DEVICE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COL

Model Number 4142

Device Problem Connection Problem (2900)

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

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

A product sample was received for evaluation.Visual and functional testing were performed.Based on the evaluation of the provided samples and investigation results the problem source for the reported by the customer difficulties is associated with compromised threads of the barrels.Based on the physical appearance the barrels were most likely affected by the molding process.The barrels are supplied components and complaint information was forwarded to the supplier quality engineer for consideration.Complaint information will continue to be monitored for any new information or adverse trends and take further actions accordingly.A device history record (dhr) review was conducted which found no issues relevant to the complaint.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that the phlebotomist are having difficulty screwing on the greiner ni-pro to the holder.No patient injury reported.

• Brand Name: JELCO VENIPUNCTURE NEEDLE-PRO SAFETY DEVICE
• 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: 15353867
• MDR Text Key: 305703908
• Report Number: 3012307300-2022-17675
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 10351688007957
• UDI-Public: 10351688007957
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2022

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
• Device Operator: Health Professional
• Device Model Number: 4142
• Device Catalogue Number: 4142
• Device Lot Number: 3965120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 09/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1