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

Model Number	4142
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3012307300-2022-17675
• Device Sequence Number: 5826114
• Product Code: JKA
• UDI-Device Identifier: 10351688007957
• UDI-Public: 10351688007957
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K922445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 09/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown