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	362799
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was report that before using bd vacutainer® ppt¿ plasma preparation tube k2e 15.8 mg there was foreign material stuck onto inner wall of 8.5ml ppt tube.This occurred 100 times.The following information was provided by the initial reporter: customer found a foreign material stuck onto the inner wall of 8.5ml ppt tube.
Additional Manufacturer Narrative
Investigation summary: "material #: 362799.Lot/batch #: 2048355.Bd had not received samples, but 3 photos were provided for investigation.The photos were reviewed and the indicated failure mode for foreign matter was observed.The nature and origin of the foreign material was not able to be identified from the photos.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 foreign matter.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." initial reporter name and address: (b)(6).

• 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 Contact: 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15276968
• Report Number: 1917413-2022-00524
• Device Sequence Number: 6486089
• Product Code: PJE
• UDI-Device Identifier: 50382903627993
• UDI-Public: 50382903627993
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2022

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: 02/28/2023
• Device Model Number: 362799
• Device Catalogue Number: 362799
• Device Lot Number: 2048355
• 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: 08/09/2022
• Initial Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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