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	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to use with the bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg, there were air bubbles.The following information was provided by the initial reporter: our blood donation teams are isolating effected tubes that they identify within the stock found in their stocks on a daily basis and although numbers are still low, air in gel has now been seen in the following lots: 2321329, 3111753, 3111754, 3111755, 3111756.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos for investigation.Therefore, 100 retention samples from bd inventory were visually inspected with no issues observed.Complaints for sample quality are under statistical control for the month of october 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 is unable to be confirmed for 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.Bd quality will continue to monitor sample quality complaints.
Event or Problem Description
It was reported that prior to use with the bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg, there were air bubbles.The following information was provided by the initial reporter: our blood donation teams are isolating effected tubes that they identify within the stock found in their stocks on a daily basis and although numbers are still low, air in gel has now been seen in the following lots: 2321329, 3111753, 3111754, 3111755, 3111756.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 18007271
• Report Number: 1917413-2023-01077
• Device Sequence Number: 6643472
• Product Code: PJE
• UDI-Device Identifier: 50382903627993
• UDI-Public: (01)50382903627993
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/15/2023

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: 04/30/2024
• Device Catalogue Number: 362799
• Device Lot Number: 3111754
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2023
• 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