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

Catalog Number	362799
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 3222674; d4.Medical device expiration date: 31-aug-2024; h4.Device manufacture date: 10-aug-2023; d4.Unique identifier (udi) #:(b)(4).D4.Medical device lot #: 3317909; d4.Medical device expiration date: 30-nov-2024; h4.Device manufacture date: 13-nov-2023; d4.Unique identifier (udi) #: (b)(4).D4.Medical device lot #: 3289116; d4.Medical device expiration date: 31-oct-2024; h4.Device manufacture date: 16-oct-2023; d4.Unique identifier (udi) #: (b)(4).A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported prior to use of bd vacutainer® ppt¿ plasma preparation tubes k2e 15.8 mg, gel air bubbles were observed as follows: lot 3222674- 75 tubes; lot 3317909 - 10 tubes; lot 3289116 - 4 tubes; lot 3257655 - 25 tubes.There was no health impact or consequences reported.
Event or Problem Description
It was reported prior to use of bd vacutainer® ppt¿ plasma preparation tubes k2e 15.8 mg, gel air bubbles were observed as follows: lot 3222674- 75 tubes; lot 3317909 - 10 tubes; lot 3289116 - 4 tubes; lot 3257655 - 25 tubes.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples, but a photo was provided for investigation.The photo was reviewed and the indicated failure mode for gel air bubbles was observed.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 the indicated failure mode of gel air bubbles.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.

• Brand Name: BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBES 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: 20639962
• Report Number: 1917413-2024-01039
• Device Sequence Number: 17984423
• Product Code: PJE
• UDI-Device Identifier: 30382903627999
• UDI-Public: (01)30382903627999(11)230914(17)240930(10)3257655
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: 362799
• Device Lot Number: 3257655
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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