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 Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 had underfill.This occurred on 100 occasions during use.The following information was provided by the initial reporter: material no.366667, batch no.9036727.It is reported customer has experienced under filling while using vacutainers.Customer is stating that this 3ml tube is periodically not filling to the fill line on the label.They do not feel it is a lot specific issue.They are investigating internally to see if there are preanalytical/drawing issues that may be a factor.
Additional Manufacturer Narrative
H.6.Investigation: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for underfill with the incident lot was not observed.Testing of the customer samples was performed and underfill was not observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformance's during manufacturing of the product.Bd has initiated further investigation relating to this issue through capa# 260774 and potential causes have been identified.As a result, corrective actions have been established and are in the process of being implemented.
Event or Problem Description
It was reported that bd vacutainer® lithium heparinn (lh) 56 usp units blood collection tubes had underfill.This occurred on 100 occasions during use.The following information was provided by the initial reporter: material no.366667, batch no.9036727 - it is reported customer has experienced under filling while using vacutainers.Customer is stating that this 3ml tube is periodically not filling to the fill line on the label.They do not feel it is a lot specific issue.They are investigating internally to see if there are preanalytical/drawing issues that may be a factor.

• 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: 9375607
• Report Number: 1917413-2019-02432
• Device Sequence Number: 16769076
• Product Code: JKA
• UDI-Device Identifier: 50382903666671
• UDI-Public: 50382903666671
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (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): 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2020
• Device Model Number: 366667
• Device Catalogue Number: 366667
• Device Lot Number: 9036727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other