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

Catalog Number	367977
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 that during use with the bd vacutainer® sst¿ blood collection tubes, the stopper came out of a tube while in the centrifuge and caused blood leakage.There was no report of impact to patient or user.
Additional Manufacturer Narrative
The following fields have been updated with additional/corrected information: d.9.Device available for eval: yes.D.9.Returned to manufacturer on: 09-may-2024.H.6.Investigation summary: bd received five(5) samples for investigation.The samples were evaluated by functional testing and the indicated failure mode for stopper pop off with the incident lot was not observed as all product specifications were met.5 customer samples were sent to franklin lakes for appropriate testing for stopper creepout/ stopper pop off.The samples were subjected to a 1st and 2nd stopper pullout test with 0 of 5 samples resulting in 2nd stopper creepout/ stopper pop off.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 stopper pop off.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 that during use with the bd vacutainer® sst¿ blood collection tubes, the stopper came out of a tube while in the centrifuge and caused blood leakage.There was no report of impact to patient or user.

• 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
• 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: 19050193
• Report Number: 1024879-2024-00315
• Device Sequence Number: 8565893
• Product Code: JKA
• UDI-Device Identifier: 00382903679775
• UDI-Public: (01)00382903679775
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/12/2024

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: 05/31/2024
• Device Catalogue Number: 367977
• Device Lot Number: 3194468
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 07/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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