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 Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/03/2020
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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that bd vacutainer® buffered sodium citrate (9nc) blood collection tubes contained foreign matter.The following information was provided by the initial reporter: "it was reported that the tube has a brown stain in the tube.The upper tube has a brown stain (lower is normal tube) and site suspect it may be contaminated.Could you send the picture for vendor and let them explain whether if this tube can be use? and why? the catalog no.Is 369714, lot no.Is 9344028.".
Event or Problem Description
It was reported that bd vacutainer® buffered sodium citrate (9nc) blood collection tubes contained foreign matter.The following information was provided by the initial reporter: "it was reported that the tube has a brown stain in the tube.The upper tube has a brown stain (lower is normal tube) and site suspect it may be contaminated.Could you send the picture for vendor and let them explain whether if this tube can be use? and why? the catalog no.Is 369714, lot no.Is 9344028.".
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples, but 1 photo was provided by the customer for investigation.The photo was reviewed and the indicated failure mode for foreign matter with the incident lot was observed.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.

• 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: 10569834
• Report Number: 1917413-2020-00859
• Device Sequence Number: 3028734
• Product Code: JKA
• UDI-Device Identifier: 50382903697149
• UDI-Public: 50382903697149
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/12/2020

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: 06/30/2021
• Device Model Number: 369714
• Device Catalogue Number: 369714
• Device Lot Number: 9344028
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/12/2020
• 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