MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER SODIUM HEPARINN (NH) 158 USP UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367874
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	07/27/2020
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 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 that during use tubes are under filling with a bd vacutainer® sodium heparinn (nh) 158 usp units blood collection tubes.The following information was provided by the initial reporter: it was reported that tubes are under filling.Customer called to report that they are having issues with the sodium heparin vacutainers, she states that they are only drawing to about 5 - 7 ml's.This has been an ongoing issue, she does have samples to return.She stated that they are testing for research purposes, and the testing they do needs a certain amount and the tubes blood volume is insufficient.
Additional Manufacturer Narrative
H.6.Investigation summary bd had not received samples or photos from the customer for evaluation.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 during use tubes are under filling with a bd vacutainer® sodium heparinn (nh) 158 usp units blood collection tubes.The following information was provided by the initial reporter: it was reported that tubes are under filling.Customer called to report that they are having issues with the sodium heparin vacutainers, she states that they are only drawing to about 5 - 7 ml's.This has been an ongoing issue, she does have samples to return.She stated that they are testing for research purposes, and the testing they do needs a certain amount and the tubes blood volume is insufficient.

• Brand Name: BD VACUTAINER SODIUM HEPARINN (NH) 158 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: 10408726
• Report Number: 1917413-2020-00703
• Device Sequence Number: 19535321
• Product Code: JKA
• UDI-Device Identifier: 50382903678742
• UDI-Public: 50382903678742
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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: 08/31/2021
• Device Model Number: 367874
• Device Catalogue Number: 367874
• Device Lot Number: 9220473
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 08/26/2020
• 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