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

Catalog Number	367820
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The actual date of event is unknown.The date received by the manufacturer has been used for this field.E1.Initial reporter phone #: (b)(6).Investigation summary: bd had not received samples, but 1 video and 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for additive abnormality with the incident lot was not observed.Additionally, 30 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to additive abnormality 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 additive abnormality.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported prior to using bd vacutainer® serum blood collection tubes that one hundred (100) tubes had an abnormal additive appearance.There was no health impact or consequence reported.
Additional Manufacturer Narrative
The following fields have been updated with additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 16-sep-2024.Investigation summary: bd received 97 samples and 1 video and 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for additive abnormality with the incident lot was not observed.Additionally, 30 randomly selected customer returned samples and 30 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to additive abnormality 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 additive abnormality.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported prior to using bd vacutainer® serum blood collection tubes that one hundred (100) tubes had an abnormal additive appearance.There was no health impact or consequence reported.

• Brand Name: BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19950361
• Report Number: 1024879-2024-00698
• Device Sequence Number: 8962189
• Product Code: JKA
• UDI-Device Identifier: 30382903678205
• UDI-Public: (01)30382903678205
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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: 01/31/2025
• Device Catalogue Number: 367820
• Device Lot Number: 3019161
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• 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