MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	369714
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that while using bd vacutainer® buffered sodium citrate (9nc) blood collection tubes the tubes had a low.This occurred on 3 separate occasions, however, there was no patient impact.The following information was provided by the initial reporter: it was reported that three blood collection tubes did not fill completely.Did any patients have to be redrawn? because these tubes were drawn in the outpatient area, staff were able to grab another tube immediately during the collection so redraws were not required for any of the 3 patients.Was there any medical intervention, if please provide the details.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples, but photos were provided by the customer for investigation.The photos were reviewed and the indicated failure mode for underfill with the incident lot was not observed, one photo shows that the customer had an issue with the product; however, no samples were received, therefore, the investigation was limited.There is no fill line on this product.Additionally, 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 non-conformances during manufacturing of the product.
Event or Problem Description
It was reported that while using bd vacutainer® buffered sodium citrate (9nc) blood collection tubes the tubes had a low.This occurred on 3 separate occasions, however, there was no patient impact.The following information was provided by the initial reporter: it was reported that three blood collection tubes did not fill completely.Did any patients have to be redrawn? because these tubes were drawn in the outpatient area, staff were able to grab another tube immediately during the collection so redraws were not required for any of the 3 patients.Was there any medical intervention, if please provide the details.

• Brand Name: BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) 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: 10869034
• Report Number: 1917413-2020-01169
• Device Sequence Number: 19573926
• Product Code: JKA
• UDI-Device Identifier: 50382903697149
• UDI-Public: 50382903697149
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• 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): 01/08/2021

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: 12/31/2021
• Device Model Number: 369714
• Device Catalogue Number: 369714
• Device Lot Number: 0167263
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1