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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported the bd vacutainer® lithium heparinn (lh) 37 usp units blood collection tubes the client experienced underfill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "during post market surveillance activity phone call, customer complained of have frequent sample underfill on bd vacutainer ®sodium fluoride tube, bd vacutainer ®lithium heparin tube, and bd vacutainer ®edta tube.She mentioned that the fluoride tube has 2021-03-31 expiration date, the lithium heparin tube has june 2021 expiration, but did not provide reference numbers or lot number for any of the tubes.".
Event or Problem Description
It was reported the bd vacutainer® lithium heparinn (lh) 37 usp units blood collection tubes the client experienced underfill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "during post market surveillance activity phone call, customer complained of have frequent sample underfill on bd vacutainer ®sodium fluoride tube, bd vacutainer ®lithium heparin tube, and bd vacutainer ®edta tube.She mentioned that the fluoride tube has 2021-03-31 expiration date, the lithium heparin tube has june 2021 expiration, but did not provide reference numbers or lot number for any of the tubes.".
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos for investigation.Therefore, 10 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.H3 other text : see h.10.

• 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: 11376196
• Report Number: 1917413-2021-00141
• Device Sequence Number: 19842949
• Product Code: JKA
• UDI-Device Identifier: 50382903666640
• UDI-Public: 50382903666640
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: 03/31/2021
• Device Model Number: 366664
• Device Catalogue Number: 366664
• Device Lot Number: 9315399
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1