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

Model Number	366668
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® serum blood collection tubes, the device experienced missing additive.The following information was provided by the initial reporter.The customer stated: it was reported that when centrifuging the serum separates into a gel like consistency and they have to centrifuge it again to complete the full separation.(b)(6): on (b)(6) 2021 17:34:31 (gmt); reference (b)(4) for same complaint on a different product number.Verbatim, "blood collection w/ cats and dogs, and when they go to separate the tubes, the serum, and some it separates into a gel like consistency, and usually the centrifuge it again and it completes the full separation.Wondering how to get it to separate the first time, they¿ve tried different temperatures/placing on ice/etc, also tried increasing centrifuge beads from 1300 to 3000g".Event date: unknown - happening since (b)(6); material no: 366668; lot no: unknown; qty: unknown.Based on the information provided, our conclusion is that the device cited meets our criteria of a complaint ¿ appendix a - complaint determination tree ¿ ((b)(4)).
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Additional Manufacturer Narrative
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.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.
Event or Problem Description
It was reported when using the bd vacutainer® serum blood collection tubes, the device experienced missing additive.The following information was provided by the initial reporter.The customer stated: it was reported that when centrifuging the serum separates into a gel like consistency and they have to centrifuge it again to complete the full separation.(b)(6): (b)(6) 2021 17:34:31 (gmt) reference (b)(4) for same complaint on a different product number.Verbatim, "blood collection w/ cats and dogs, and when they go to separate the tubes, the serum, and some it separates into a gel like consistency, and usually the centrifuge it again and it completes the full separation.Wondering how to get it to separate the first time, they¿ve tried different temperatures/placing on ice/etc, also tried increasing centrifuge beads from 1300 to 3000g".Event date: unknown - happening since april.Material no: 366668, lot no: unknown, qty: unknown.Based on the information provided, our conclusion is that the device cited meets our criteria of a complaint ¿ appendix a - complaint determination tree ¿ (nassc-rcc-007).*see case comments for related case on a different material number.

• Brand Name: BD VACUTAINER® SERUM BLOOD COLLECTION TUBE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13005112
• Report Number: 1024879-2021-00859
• Device Sequence Number: 13926685
• Product Code: JKA
• UDI-Device Identifier: 50382903666688
• UDI-Public: 50382903666688
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

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 Model Number: 366668
• Device Catalogue Number: 366668
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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