MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® ACD SOLUTION A BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	364606
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	03/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to use with the bd vacutainer® acd solution a blood collection tubes, an unspecified number of tubes had foreign matter on the stopper, on the outside of the tube, and/or on the inside of the tube.There was no report of patient impact.
Additional Manufacturer Narrative
H6.Investigation summary: bd received five (5) samples and fourteen (14) photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for foreign matter (fm) on the stopper and tube was observed.Additionally, the customer samples were evaluated by visual examination and the indicated failure mode for fm on the stopper and tube with the incident lot 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, foreign matter.Bd was not able to identify a root cause for the indicated failure mode.However, there has been increased awareness for cleanliness and reduction of fm in the plant.Several projects are in place that will help reduce the potential of introducing fm into tubes.A team has also been established that¿s focus is fm awareness and reduction.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.
Additional Manufacturer Narrative
The following fields were updated: d9.Device available for evaluation? yes.Returned to manufacturer on: 10-apr-2024.Investigation summary.Bd received five (5) samples and fourteen (14) photos for investigation.Visual examination of the samples and photos was performed and revealed foreign matter (fm) on the stopper and the tube.Additionally, the customer samples were evaluated by fourier transform infrared spectroscopy (ftir) testing.The unidentified matter(um) embedded in the rubber stopper sample is consistent with the rubber itself indicating it is discolored stopper rubber material.The um on the glass surface is consistent with stopper lubricant.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 an exact root cause for the indicated failure mode.However, there has been increased awareness for cleanliness and reduction of fm in the plant.Several projects are in place that will help reduce the potential of introducing fm into tubes.A team has also been established that¿s focus is fm awareness and reduction.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.
Event or Problem Description
It was reported that prior to use with the bd vacutainer® acd solution a blood collection tubes, an unspecified number of tubes had foreign matter on the stopper, on the outside of the tube, and/or on the inside of the tube.There was no report of patient impact.

• Brand Name: BD VACUTAINER® ACD SOLUTION A BLOOD COLLECTION TUBES
• 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: 19163065
• Report Number: 1917413-2024-00340
• Device Sequence Number: 17972878
• Product Code: JKA
• UDI-Device Identifier: 30382903646068
• UDI-Public: (01)30382903646068
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: BK210649
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2024

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: 12/31/2025
• Device Catalogue Number: 364606
• Device Lot Number: 3352625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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