MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	367326
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.1 required field in the next state medical device type: fpa, jka.E.1 initial reporter facility name: (b)(6) hospital.G.5 pma / 510(k)#k030573, k220212.H.3.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 while using the bd vacutainer® push button blood collection set that there was a blood leak.No patient impact.
Event or Problem Description
It was reported that while using the bd vacutainer® push button blood collection set that there was a blood leak.No patient impact.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information: device available for eval? yes.Returned to manufacturer on 29-feb-24.Device return to manuf.? yes.Device eval by manufacturer? yes.Investigation exec summary: material #: 367326.Lot/batch #: 3104074.Bd received three (3) samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for leakage with the incident lot was observed.All three samples failed testing.One of the samples the tubing appeared slice with blood leakage through the cut.Another of the samples had blood leakage on the sleeve.The last sample had blood leakage around the luer of the device.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 has been confirmed for the indicated failure mode leakage.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.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET
• 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: 18328814
• Report Number: 1024879-2023-00900
• Device Sequence Number: 7129637
• Product Code: FPA
• UDI-Device Identifier: 50382903673266
• UDI-Public: (01)50382903673266
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K030573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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: 04/30/2025
• Device Catalogue Number: 367326
• Device Lot Number: 3104074
• 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: 11/21/2023
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2023
• 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