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

Model Number	366882
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	12/03/2019
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 the bd vacutainer® sst¿ ii advance plus blood collection tube experienced blood pooling in the stopper well during use.The following information was provided by the initial reporter: blood pooling in sstii 2,5 ml 366882 with lot 9128593.During a blood collection in the hospital, blood pooling was noticed in the sstii 2,5 ml tube 366882 with lot number 91285593.This blood droplet came loose from the stopper which causes the risk of blood contact.
Event or Problem Description
It was reported that the bd vacutainer® sst¿ ii advance plus blood collection tube experienced blood pooling in the stopper well during use.The following information was provided by the initial reporter: blood pooling in sstii 2,5 ml 366882 with lot 9128593.During a blood collection in the hospital, blood pooling was noticed in the sstii 2,5 ml tube 366882 with lot number 91285593.This blood droplet came loose from the stopper which causes the risk of blood contact.
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 observed.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.H3 other text : see h.10.

• 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: 9489812
• Report Number: 9617032-2019-01475
• Device Sequence Number: 13888821
• 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): 02/11/2020

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 Expiration Date: 05/31/2020
• Device Model Number: 366882
• Device Catalogue Number: 366882
• Device Lot Number: 9128593
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/11/2020
• 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