MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® NO ADDITIVE (Z) TUBES; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number	366704
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that while using bd vacutainer® no additive (z) tubes the tubes underfilled.The following information was provided by the initial reporter: this product is a 3.0ml serum tube, but they have discovered that it isn't drawing 3.0ml.It is only drawing about 2.1ml.One photo is a syringe filled with the volume that the vacutainers are drawing up to show the volume is not 3ml.The other is a tube on the left with the volume they are drawing.The tube to the right was manually filled with 3ml and is clearly more filled.
Event or Problem Description
It was reported that while using bd vacutainer® no additive (z) tubes the tubes underfilled.The following information was provided by the initial reporter: this product is a 3.0ml serum tube, but they have discovered that it isn't drawing 3.0ml.It is only drawing about 2.1ml.One photo is a syringe filled with the volume that the vacutainers are drawing up to show the volume is not 3ml.The other is a tube on the left with the volume they are drawing.The tube to the right was manually filled with 3ml and is clearly more filled.
Additional Manufacturer Narrative
The following fields have been updated with additional/corrected information: d.4.Device available for eval: yes d.4.Returned to manufacturer on: 08-dec-2023.H.6.Investigation summary: 10 samples and 2 photos were returned by the customer in support of this complaint.The photos were evaluated and do show the customer¿s failure mode of underfill.The quantity of blood drawn into evaluated tubes varies with altitude, ambient temperature, barometric pressure, tube age, venous pressure, and filling technique.10 sample tubes were draw tested.All tubes were within specification limits.10 production lot in-house retention tubes samples were draw tested.All tubes were within specification limits.Bd was able to confirm the customer¿s indicated failure mode with the photos provided; however, the defect was not observed in the sample and retention testing.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VACUTAINER® NO ADDITIVE (Z) TUBES
• Common Device Name: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• 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: 18229919
• Report Number: 1917413-2023-01183
• Device Sequence Number: 6222332
• Product Code: FMH
• UDI-Device Identifier: 50382903667043
• UDI-Public: (01)50382903667043
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

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: 12/31/2023
• Device Catalogue Number: 366704
• Device Lot Number: 2166011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• 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