MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO BLOOD COLLECTION SAF-T HOLDER SHARPS SAFETY; CATHETER, INTRAVASCULAR, THERAPEUTIC,

Model Number	96000
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported per mw5105872: a nurse removed saf-t holder device and went to flush the central line to clear it of blood and noticed that there was a white piece of something in the valve on the iv line and noticed air moving from the valve to the patient.The line was cleared with no incident.No patient injury was reported.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4).As a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No problems or issues were identified during this device history record review.

• Brand Name: JELCO BLOOD COLLECTION SAF-T HOLDER SHARPS SAFETY
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC,
• 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: 16560013
• Report Number: 3012307300-2023-02664
• Device Sequence Number: 20247401
• Product Code: JKA
• UDI-Device Identifier: 20351688062953
• UDI-Public: 20351688062953
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K923090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2023

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: 02/10/2026
• Device Model Number: 96000
• Device Catalogue Number: 96000
• Device Lot Number: 4106947
• Was Device Available for Evaluation?: No
• 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: 03/09/2023
• Initial Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2021
• 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