MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS

Model Number	96000
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.The returned samples consist of two (2) saf-t-wing product, the returned samples were received in new condition with its original closed package.Visual inspection shows the samples were visually inspected, at 12" to 16" and normal conditions of illumination.Results shows one sample observe the luer of the saf-t holder product broken, the other sample no defect found.Per preview complaints a review of manufacturing process was conducted by quality engineer, in order to verify that there are no situations or practices that could create the event as described in description of non-conformance" section.In order to reproduce the failure mode reported by customer, we make the following test using pre-sterile and post-sterile material.Production performs a 100% in process inspection, in order to verify for damage or cracked sections in the male luer.In the packaging area, production performs a 100% in process inspection, in order to verify that the products are free of damage in the male luer.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.The luer come weak from supplier.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 in conjunction with the pvk setting with blue nexiva, blood culture is taken from the pvk by means of saftholder which is connected to the pvk and the blood samples are taken.When the saftholder is then disconnected from the pvk, it has broken and a piece of plastic remains in the pvk mouth.Unable to remove plastic and hose to pvk must be replaced.No patient injury was reported.

• Brand Name: JELCO
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS
• 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: 15445301
• Report Number: 3012307300-2022-19604
• Device Sequence Number: 4679727
• Product Code: JKA
• UDI-Device Identifier: 20351688062953
• UDI-Public: 20351688062953
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K923090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/19/2022

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: 09/05/2023
• Device Model Number: 96000
• Device Catalogue Number: 96000
• Device Lot Number: 3693972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2018
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown