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

Catalog Number	366882
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that blood pooling occurred during use with a bd vacutainer® sst¿ ii advance plus blood collection tubes.The following information was provided by the initial reporter, "blood pooling in stopper of sstii 2,5ml 366882 lot 9128593 in combo with pb utw 23g 367364.A sstii 2,5ml 366882 lot 9128593 showed blood pooling in the hemogard stopper when filled with the pb utw 23g 367364 lot 9011664.This tube was the 4th in the drawn order.Upon mixing the tube the blood in the stopper gets loose and falls on the patient's clothes, the nurse's apron and the phlebotomy trolley (splatter).This already happened before but was not communicated to bd.".
Event or Problem Description
It was reported that blood pooling occurred during use with a bd vacutainer® sst¿ ii advance plus blood collection tubes.The following information was provided by the initial reporter, "blood pooling in stopper of sstii 2,5ml 366882 lot 9128593 in combo with pb utw 23g 367364.A sstii 2,5ml 366882 lot 9128593 showed blood pooling in the hemogard stopper when filled with the pb utw 23g 367364 lot 9011664.This tube was the 4th in the drawn order.Upon mixing the tube the blood in the stopper gets loose and falls on the patient's clothes, the nurse's apron and the phlebotomy trolley (splatter).This already happened before but was not communicated to bd.".
Additional Manufacturer Narrative
Investigation: bd had not received samples or photos from the customer facility for evaluation.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed relating to blood pooling or spillage as all samples met specifications.A review of the device history record was completed for the incident lot and, based on this review, 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® 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: 9356362
• Report Number: 9617032-2019-01327
• Device Sequence Number: 2697075
• Product Code: JKA
• UDI-Device Identifier: 50382903668828
• UDI-Public: 50382903668828
• 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): 12/20/2019

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 Expiration Date: 05/31/2020
• Device Catalogue Number: 366882
• Device Lot Number: 9128593
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/20/2019
• 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