MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	366444
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No expiration date is available.No manufacture date is available.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® sst¿ ii advance plus blood collection tubes had blood pooling in the stopper well.The following information was provided by the initial reporter: "complaint came in through a lab technician who works at several different zna sites.She also performs nightly blood collections.She noticed blood drops on the closure of the vacutainer tubes (different tubes, different lot numbers).These drops foul the collection bags, used to transport the tubes to the lab (see picture attached).Also, when the drops are dried, the fall of on the table in the lab.".
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for blood pooling with the incident lot was not observed.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.
Event or Problem Description
It was reported that bd vacutainer® sst¿ ii advance plus blood collection tubes had blood pooling in the stopper well.The following information was provided by the initial reporter: "complaint came in through a lab technician who works at several different zna sites.She also performs nightly blood collections.She noticed blood drops on the closure of the vacutainer tubes (different tubes, different lot numbers).These drops foul the collection bags, used to transport the tubes to the lab (see picture attached).Also, when the drops are dried, the fall of on the table in the lab.".

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 9644877
• Report Number: 9617032-2020-00052
• Device Sequence Number: 2495312
• Product Code: JKA
• UDI-Device Identifier: 50382903664448
• UDI-Public: 50382903664448
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: BK050036
• 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): 04/06/2020

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 Model Number: 366444
• Device Catalogue Number: 366444
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 04/06/2020
• 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