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 Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
Material no: 366444 batch no: 8036515.It was reported that during use of the bd vacutainer® sst¿ ii advance plus blood collection tubes testing indicates both nominal and maximum dosed did not meet the product specification for draw volume of -19% of labelled draw at test intervals.The following information was provided by the initial reporter: as part of capa (b)(4), we sourced bd vacutainer® sst 5.0 ml (368970), 3.5 ml (368967) and 6.0 ml (366444) tubes which were sterilized at nominal (~22.6 kgy) and maximum dose levels (~32.3 kgy) for draw volume testing.The testing indicates both nominal and maximum dosed bd vacutainer® sst 5.0, 3.5 and 6.0 ml tubes did not meet the product specification for draw volume of -19% of labelled draw at below mentioned test intervals.Please refer below graphs for details.Irradiation dose (kgy): maximum 30.6-31.7.Test interval (months): t=19.
Additional Manufacturer Narrative
Date of event was provided and parent record has been updated.Date of event: (b)(6) 2019.
Event or Problem Description
Material no: 366444 batch no: 8036515.It was reported that during use of the bd vacutainer® sst¿ ii advance plus blood collection tubes testing indicates both nominal and maximum dosed did not meet the product specification for draw volume of -19% of labelled draw at test intervals.The following information was provided by the initial reporter: as part of capa 54720, we sourced bd vacutainer® sst 5.0 ml (368970), 3.5 ml (368967) and 6.0 ml (366444) tubes which were sterilized at nominal (~22.6 kgy) and maximum dose levels (~32.3 kgy) for draw volume testing.The testing indicates both nominal and maximum dosed bd vacutainer® sst 5.0, 3.5 and 6.0 ml tubes did not meet the product specification for draw volume of -19% of labelled draw at below mentioned test intervals.Please refer below graphs for details.Irradiation dose (kgy): maximum 30.6-31.7.Test interval (months): t=19.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer facility for evaluation.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.
Event or Problem Description
Material no: 366444 batch no: 8036515 it was reported that during use of the bd vacutainer® sst¿ ii advance plus blood collection tubes testing indicates both nominal and maximum dosed did not meet the product specification for draw volume of -19% of labelled draw at test intervals.The following information was provided by the initial reporter: as part of capa 54720, we sourced bd vacutainer® sst 5.0 ml (368970), 3.5 ml (368967) and 6.0 ml (366444) tubes which were sterilized at nominal (~22.6 kgy) and maximum dose levels (~32.3 kgy) for draw volume testing.The testing indicates both nominal and maximum dosed bd vacutainer® sst 5.0, 3.5 and 6.0 ml tubes did not meet the product specification for draw volume of -19% of labelled draw at below mentioned test intervals.Please refer below graphs for details.Irradiation dose (kgy): maximum 30.6-31.7 test interval (months): t=19.

• 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: 9490596
• Report Number: 9617032-2019-01480
• Device Sequence Number: 2235046
• Product Code: JKA
• UDI-Device Identifier: 50382903664448
• UDI-Public: 50382903664448
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: BK050036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2020

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: 07/31/2019
• Device Model Number: 366444
• Device Catalogue Number: 366444
• Device Lot Number: 8036515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 09/20/2019; 09/20/2019
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 12/26/2019; 01/13/2020
• 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