MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER LITHIUM HEPARINN (LH) 37 USP UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	366664
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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) 37 usp units blood collection tubes underfilled.The following information was provided by the initial reporter: " it was reported that tubes are underfilling.Customer called to see what the fill volumes are for tubes, she is reporting that tubes are underfilling.Issue has occurred a couple of times.No known date.This is a new tube and they need some clarification on the draw volume.Samples are available.Tubes are filling to about 0.5 ml short of the 2ml.".
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: 5/26/2021.H.6.Investigation: bd received (b)(4) samples for investigation.The samples were evaluated by functional testing and the indicated failure mode for 'underfill' with the incident lot was not observed.Additionally, (b)(4) retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to 'underfill' as all samples met specifications.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.Bd was not able to identify a root cause for the indicated failure mode.
Event or Problem Description
It was reported that bd vacutainer® lithium heparinn (lh) (b)(4) usp units blood collection tubes underfilled.The following information was provided by the initial reporter: " it was reported that tubes are underfilling.Customer called to see what the fill volumes are for tubes, she is reporting that tubes are underfilling.Issue has occurred a couple of times.No known date.This is a new tube and they need some clarification on the draw volume.Samples are available.Tubes are filling to about 0.5 ml short of the 2ml.".

• Brand Name: BD VACUTAINER LITHIUM HEPARINN (LH) 37 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: 11881499
• Report Number: 1917413-2021-00445
• Device Sequence Number: 1413418
• Product Code: JKA
• UDI-Device Identifier: 50382903666640
• UDI-Public: 50382903666640
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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 Expiration Date: 03/31/2022
• Device Model Number: 366664
• Device Catalogue Number: 366664
• Device Lot Number: 0316318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1