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

Catalog Number	362800
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd vacutainer ppt k2e 15.8 mg an unspecified number of tubes had a vacuum issue resulting in underfilled tubes.There was no health impact or consequences reported.
Additional Manufacturer Narrative
E1.Initial reporter addr 1: (b)(6).Investigation summary: bd received 20 samples and 2 photos from the customer for investigation of underfill.The photos were reviewed and underfill was observed, as the specimen volume drawn into tubes was lower than the draw volume for this product.Per specification, tube does not have a fill line.In addition, a draw test was performed on the 20 returned samples and retention samples from bd inventory, and all tubes were within specification limits.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 underfill based on the photos.Bd was unable to identify a root cause for indicated failure mode.Complaints received for this device and the condition reported will continue to be tracked and evaluated.Our business team regularly analyzes collected data to identify emerging trends.

• Brand Name: BD VACUTAINER® PPT¿ K2E 15.8 MG
• Common Device Name: BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING
• 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: 19767931
• Report Number: 1917413-2024-00648
• Device Sequence Number: 8778549
• Product Code: PJE
• UDI-Device Identifier: 50382903628006
• UDI-Public: (01)50382903628006
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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: 09/30/2024
• Device Catalogue Number: 362800
• Device Lot Number: 3257657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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