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

Catalog Number	362799
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: d2b: medical device type: jka & pje.E1: initial reporter facility name: (b)(6).H3.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 that the user found, prior to use, two tubes with abnormal additive.No health impact or consequence reported.
Additional Manufacturer Narrative
H.6.Investigation summary: no samples and 4 photos were returned by the customer in support of this complaint from catalog 362799, lot number 3048739.Visual examination of the photos was performed and revealed additive abnormality.The tubes have large droplets of additive on the inside wall of the tube from rundown of the additive when additive is applied onto the interior walls of the blood collection vessel via the spray coating of the prescribed amount of water-based solution.The water is then dried, leaving the characteristic ¿mist¿ dot pattern of residual solution on the vessel wall.In rare instances where assembly machine misalignments occur, additive dispense nozzles may not be centered within the tubes¿ opening and the nozzles¿ position is biased more towards one of the vessels¿ hemispheres.In such instanced, one side (or hemisphere) of the tube vessel interior received a heavier coating of additive solution, while points on the opposing side of vessel receive a lighter misting.Larger droplets of the solution in close proximity to one another than tend to coalesce, and once the water is dried, leave behind a wafer like deposit of the additive.This additive deposit visually stands out as it does not appear like the typical dot pattern for this tube type.Bd was able to confirm the customer¿s indicated failure mode with the investigation completed.The exact cause for the customer¿s failure mode could not be determined.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported when using the bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg that the user found, prior to use, two tubes with abnormal additive.No health impact or consequence reported.

• 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
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18507604
• Report Number: 1917413-2023-01343
• Device Sequence Number: 15475680
• Product Code: PJE
• UDI-Device Identifier: 50382903627993
• UDI-Public: (01)50382903627993
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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: 02/29/2024
• Device Catalogue Number: 362799
• Device Lot Number: 3048739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2023
• 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