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); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2021
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 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 when using the bd vacutainer® buffered sodium citrate (9nc) blood collection tubes the user reported underfilling or low draw of two tubes and missing label along with missing or no label information.This event occurred two times.The following information was provided by the initial reporter: translated to english.The customer stated: "customer questions about the correct way to collect in the 4.5 ml citrate tube, as it does not have a mark indicating how far it can be collected.She reported in this questioning that when they perform vacuum collection, the tube fills only 20%, around 2 ml".
Event or Problem Description
It was reported when using the bd vacutainer® buffered sodium citrate (9nc) blood collection tubes the user reported underfilling or low draw of two tubes and missing label along with missing or no label information.This event occurred two times.The following information was provided by the initial reporter: translated to english.The customer stated: "customer questions about the correct way to collect in the 4.5 ml citrate tube, as it does not have a mark indicating how far it can be collected.She reported in this questioning that when they perform vacuum collection, the tube fills only 20%, around 2 ml.".
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.

• 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: 11322668
• Report Number: 1917413-2021-00088
• Device Sequence Number: 19864945
• Product Code: JKA
• UDI-Device Identifier: 50382903697149
• UDI-Public: 50382903697149
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (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): 02/24/2021

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: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 369714
• Device Catalogue Number: 369714
• Device Lot Number: 0133407
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1