MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER SST BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367987
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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¿ blood collection tubes, the device experienced underfill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: it is reported customer is experiencing under filling.Tiger top sst 7.5ml, many of the tubes do not have a vacuum in them, seems to be random in that lot.
Event or Problem Description
It was reported when using the bd vacutainer® sst¿ blood collection tubes, the device experienced underfill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: it is reported customer is experiencing under filling.Tiger top sst 7.5ml, many of the tubes do not have a vacuum in them, seems to be random in that lot.
Additional Manufacturer Narrative
Investigation: bd had not received samples or photos for investigation.Therefore, thirty (30) retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to underfill 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 underfill.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BD VACUTAINER SST BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 12502292
• Report Number: 1024879-2021-00644
• Device Sequence Number: 14503205
• Product Code: JKA
• UDI-Device Identifier: 50382903679879
• UDI-Public: 50382903679879
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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 Expiration Date: 01/31/2022
• Device Model Number: 367987
• Device Catalogue Number: 367987
• Device Lot Number: 1034773
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1