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

Model Number	366667
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported when using the bd vacutainer® lithium heparinn (lh) 56 usp units blood collection tubes, the device experienced insufficient additive quantity.The following information was provided by the initial reporter.The customer stated: it was reported that the tube have a lack of gel in the bottom of them.Cannot use these lithium tubes due to the lack of gel in the bottom.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 7/19/2021 h.6.Investigation: bd received one thousand (1000) samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for missing gel with the incident lot was not observed.This product met specifications because it is not manufactured to have a gel additive.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 the indicated failure mode of missing gel.Bd was able to determine that the product was manufactured to specifications.H3 other text : see h.10.
Event or Problem Description
It was reported when using the bd vacutainer® lithium heparinn (lh) 56 usp units blood collection tubes, the device experienced insufficient additive quantity.The following information was provided by the initial reporter.The customer stated: it was reported that the tube have a lack of gel in the bottom of them.Cannot use these lithium tubes due to the lack of gel in the bottom.

• 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
• MDR Report Key: 12193638
• Report Number: 1917413-2021-00649
• Device Sequence Number: 19693241
• Product Code: JKA
• UDI-Device Identifier: 50382903666671
• UDI-Public: 50382903666671
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 08/03/2021

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 Model Number: 366667
• Device Catalogue Number: 366667
• Device Lot Number: UNKNOOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1