MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VACUETTE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number	456287P
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Gel barrier tubes arriving to the lab with large amounts of gel stuck to the sides of the tubes/floating in the plasma resulting in persistent interruptions to specimen testing due to gel clogging sampling probes on the chemistry analyzers.While multiple lot numbers of tubes have had this issue the current primary lot we are seeing excessive gel is lot # b2303374.We received this lot number from at least 17 phlebotomy sites with gel issues occurring at each.

• Brand Name: VACUETTE
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): GREINER BIO-ONE GMBH; 4238 capital drive; monroe NC 28110
• MDR Report Key: 18865232
• Report Number: 18865232
• Device Sequence Number: 20892899
• Product Code: JKA
• UDI-Device Identifier: 29120049204674
• UDI-Public: (01)29120049204674
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/19/2023
• Report Date (Section F): 12/19/2023

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
• Device Model Number: 456287P
• Device Catalogue Number: 456287P
• Device Lot Number: B2303374
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/19/2023