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

Model Number	367987
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.Technical services contacted the customer to provide troubleshooting suggestions.They also provided the instruction for use (ifu) and troubleshooting hemolysis chart.
Event or Problem Description
It was reported when using the bd vacutainer¿ sst" blood collection tube there was hemolysis.The following information was provided by the initial reporter.The customer stated: "we have been experiencing hemolysis for the past couple of months.No specific date of event, no amount of occurrences, no batch number, no samples available, no photos available, no medical intervention, no erroneous results.Customer doesn't require acknowledgement nor closure letter as he is only requesting tech services." (b)(6) 2021 spoke with the customer and reviewed tourniquet use and processing.Customer stated the tubes are unspun and sent from (b)(6) to (b)(6) on ice, about 24 hours in transport time.Teaching provided regarding that centrifuge within 2 hours of collection and then transported at rt conditions, tubes in contact with the ice will cause lysis the cells and hemolysis may occurr.Ifu and the troubleshooting hemolysis chart was provided.
Event or Problem Description
It was reported when using the bd vacutainer® sst¿ blood collection tube there was hemolysis.The following information was provided by the initial reporter.The customer stated: "we have been experiencing hemolysis for the past couple of months.No specific date of event, no amount of occurrences, no batch number, no samples available, no photos available, no medical intervention, no erroneous results.Customer doesn't require acknowledgement nor closure letter as he is only requesting tech services.".2/1/2021 spoke with the customer and reviewed tourniquet use and processing.Customer stated the tubes are unspun and sent from (b)(6) on ice, about 24 hours in transport time.Teaching provided regarding that centrifuge within 2 hours of collection and then transported at rt conditions, tubes in contact with the ice will cause lysis the cells and hemolysis may "occur".Ifu and the troubleshooting hemolysis chart was provided.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.The complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.

• 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: 11362369
• Report Number: 1024879-2021-00119
• Device Sequence Number: 715183
• Product Code: JKA
• UDI-Device Identifier: 50382903679879
• UDI-Public: 50382903679879
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/17/2021

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 Model Number: 367987
• Device Catalogue Number: 367987
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1