MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367964
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.1 medical device brand name: bd vacutainer® pst¿ gel and lithium "heparin" (lh) 126 units blood collection tubes.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using the bd vacutainer® pst¿ gel and lithium "heparin" (lh) 126 units blood collection tubes that there was poor barrier separation of the sample.The following information was provided by the initial reporter: customer states tubes exhibit rbcs in the gel post centrifugation and after refrigeration.Customer states samples are drawn and let sit at rt for a minimum of 30 minutes before centrifugation.Samples are centrifuged for 10 minutes and then refrigerated at 2-8c.When samples removed from the refrigerator it look as if the gel has absorbed the red cells from the bottom of the tube.Customer states rbcs are absorbed into gel post centrifugation and after they have been refrigerated.
Additional Manufacturer Narrative
The following fields have been updated with additional/corrected information: device available for evalution?: yes returned to manufacturer on: 27-sep-2023 h.6.Investigation summary: bd received 5 samples and 6 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for poor barrier separation was observed.Additionally, the customer samples and retention samples from the same lot number were visually inspected with no issues observed.Complaints for sample quality are under statistical control for the month of september 2023.At this time, further testing is not indicated.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for poor barrier separation.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.Bd quality will continue to monitor sample quality complaints.H3 other text : see h.10.
Event or Problem Description
It was reported that while using the bd vacutainer® pst¿ gel and lithium heparinn (lh) 126 units blood collection tubes that there was poor barrier separation of the sample.The following information was provided by the initial reporter: customer states tubes exhibit rbcs in the gel post centrifugation and after refrigeration.Customer states samples are drawn and let sit at rt for a minimum of 30 minutes before centrifugation.Samples are centrifuged for 10 minutes and then refrigerated at 2-8c.When samples removed from the refrigerator it look as if the gel has absorbed the red cells from the bottom of the tube.Customer states rbcs are absorbed into gel post centrifugation and after they have been refrigerated.

• Brand Name: SEE H.10
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17859874
• Report Number: 1917413-2023-00952
• Device Sequence Number: 14934934
• Product Code: JKA
• UDI-Device Identifier: 50382903679640
• UDI-Public: 50382903679640
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

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: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 367964
• Device Lot Number: 2354033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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