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

Catalog Number	367957
Medical Device Problem Code	Overfill (2404)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field."multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1350530; medical device expiration date: unknown; device manufacture date: unknown.Medical device lot #: 2025450; medical device expiration date: unknown; device manufacture date: unknown.Lot #: lot# 2025450 does not exist for material # 366882.Lot #: lot# 1350530 does not exist for material # 366882.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 when using the bd vacutainer® sst¿ ii advance plus blood collection tubes, the device experienced overfill.The following information was provided by the initial reporter.The customer stated: we are experiencing right now that the yellow glasses we use are overfilled.Normally there is a vaccine which causes them to automatically stop drawing blood, but it is as if there is an increased vaccine so that they become overfilled.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 25-may-2022 h.6.Investigation: bd received 20 samples from lot number 2025450 for investigation.No samples were received from lot number 1350530.The samples were evaluated by functional draw testing, each drawn with deionized water, and the indicated failure mode for overfill with the incident lot was not observed.Additionally, twenty (20) retention samples of each reported lot from bd inventory were evaluated by functional draw testing, each drawn with deionized water, and no issues were observed relating to overfill as all 40 samples met specifications.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 issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode of overfill.Bd was not able to identify a root cause for the indicated failure mode.See h.10.
Event or Problem Description
It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes, the device experienced overfill.The following information was provided by the initial reporter.The customer stated: we are experiencing right now that the yellow glasses we use are overfilled.Normally there is a vaccine which causes them to automatically stop drawing blood, but it is as if there is an increased vaccine so that they become overfilled.
Event or Problem Description
It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes, the device experienced overfill.The following information was provided by the initial reporter.The customer stated: we are experiencing right now that the yellow glasses we use are overfilled.Normally there is a vaccine which causes them to automatically stop drawing blood, but it is as if there is an increased vaccine so that they become overfilled.
Additional Manufacturer Narrative
The information provided in this section describes the changes made from the original mdr task.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 1350530.D.4.Medical device expiration date: 2023-06-30.H.4.Device manufacture date: 2021-12-16.D.4.Medical device lot #: 2025450.D.4.Medical device expiration date: 2023-07-31.H.4.Device manufacture date: 2022-01-25.D.4.Medical device catalog number: 367957.Imdrf annex g grid (1).Imdrf annex b grid (3) : b02,b14, b17.Imdrf annex c grid (1)l : c19.Imdrf annex d grid : d14.H.6.Investigation summary: "bd had not received samples or photos for investigation.If samples are received at a later date the record will be reopened and investigated accordingly.Therefore, twenty (20) retention samples of each lot from bd inventory were evaluated by functional testing and no issues were observed relating to overfill as all samples met specifications.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 issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode of overfill.Bd was not able to identify a root cause for the indicated failure mode.Our business team regularly reviews the collected data for identification of emerging trends.".

• 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
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14251283
• Report Number: 9617032-2022-00433
• Device Sequence Number: 4397950
• Product Code: JKA
• UDI-Device Identifier: 00382903668823
• UDI-Public: 00382903668823
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: BK050036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2022

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 Catalogue Number: 367957
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 05/10/2022; 05/31/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 05/16/2022; 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown