MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 15.8 MG; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	362800
Medical Device Problem Codes	Fluid/Blood Leak (1250); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 when using the bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg there were tube extenders with molding defects that can be used.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: "the tubes appear collapsed at one side of the tube and were noticed by the phlebotomist prior to taking blood.".
Additional Manufacturer Narrative
H6: investigation summary bd had not received samples, but photos were provided by the facility for investigation.The photos were evaluated and the indicated failure mode for collapsed tubes with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Bd is continually monitoring complaints received for this device and reported condition in order to identify emerging trends.Note that there are potentially varying degrees of tube collapse, based on the temperature and duration of time at elevated temperature.Mildly collapsed tubes will retain vacuum and only show minimal deformation.Mildly collapsed tubes will draw appropriately but may not be able to be processed on laboratory instruments (e.G.May be slightly bowed and no longer fit in a rack).As long as the vacuum is retained and the tube fills appropriately, the tube will function properly.Fully collapsed tubes appear flattened, twisted, and visibly deformed.Fully collapsed tubes retain little or no vacuum and therefore cannot be drawn to an appreciable volume.These tubes are easily identified before use by the healthcare worker, so there is no potential impact to the patient.H3 other text : see h10.
Event or Problem Description
It was reported when using the bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg there were tube extenders with molding defects that can be used.This event occurred 5 times.The following information was provided by the initial reporter.The customer stated: "the tubes appear collapsed at one side of the tube and were noticed by the phlebotomist prior to taking blood.".

• Brand Name: BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 15.8 MG
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 12189096
• Report Number: 1917413-2021-00642
• Device Sequence Number: 3035932
• Product Code: JKA
• UDI-Device Identifier: 50382903628006
• UDI-Public: 50382903628006
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K972075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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: 01/31/2022
• Device Model Number: 362800
• Device Catalogue Number: 362800
• Device Lot Number: 1014031
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1