MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® LITHIUM HEPARINN (LH) 56 USP UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366667
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 that bd vacutainer® lithium heparinn (lh) 56 usp units blood collection tubes low fill volume occurred in at least half of the tubes of 1 box.No patient impact occurred.The following information was provided by the initial reporter: customer reports low fill volumes in at least half of the tubes from 1 box of lot#: 2321348.
Additional Manufacturer Narrative
H.6.Investigation summary: bd received four (4) samples for investigation.The samples were used; therefore, the investigation was limited to visual examination.The samples have a specimen in the tubes that is below the fill line on the tube label.The puncture marks are not in the center of the conventional stopper well.The indicated failure mode for underfill with the incident lot was observed.One hundred (100) retention samples from bd inventory were evaluated by visual examination with the hemogard closure assembly correctly assembled and placed on the tubes.Additionally, ten (10) retention samples from bd inventory were evaluated by functional draw testing and no issues were observed relating to underfill as all samples met specifications.The following fields were updated due to additional information: d9: device available for evaluation:  yes d9: returned to manufacturer on: 2023-07-25.
Event or Problem Description
It was reported that bd vacutainer® lithium heparinn (lh) 56 usp units blood collection tubes low fill volume occurred in at least half of the tubes of 1 box.No patient impact occurred.The following information was provided by the initial reporter: customer reports low fill volumes in at least half of the tubes from 1 box of lot#: 2321348.

• Brand Name: BD VACUTAINER® LITHIUM HEPARINN (LH) 56 USP UNITS 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17455484
• Report Number: 1917413-2023-00731
• Device Sequence Number: 2712394
• Product Code: JKA
• UDI-Device Identifier: 50382903666671
• UDI-Public: 50382903666671
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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: 03/31/2024
• Device Catalogue Number: 366667
• Device Lot Number: 2321348
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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