MAUDE Adverse Event Report: VIAL; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number	3459
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During production, a number of labels with a wrong item number have been printed and attached to the product.The release control did not find this few labels, as there is not currently a total control of all attached labels.In total 25 mislabels vials out of 551 have been identified.Pneumococcus cwps; (b)(6).Fda safety report id # (b)(4).

• Brand Name: VIAL
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• MDR Report Key: 11036899
• Report Number: MW5098447
• Device Sequence Number: 13725151
• Product Code: JKA
• UDI-Device Identifier: 05713106034590
• UDI-Public: 5713106034590
• Initial Reporter Country: DA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

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: 01/09/2024
• Device Model Number: 3459
• Device Lot Number: ZCWPS1-1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other