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

Catalog Number	367326
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: d.2.Common device name: intravascular administration set d.2.Medical device type: fpa g.5.Pma/510(k)#: k030573, k220212.H.3.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It has been reported that the bd vacutainer® push button blood collection set has been found experiencing blood leakage during use.The following has been provided by the initial reporter: this is a complaint about blood leak.A customer pointed out that there was blood leakage during blood collection with the push button (21g) of the winged needle.
Event or Problem Description
It has been reported that the bd vacutainer® push button blood collection set has been found experiencing blood leakage during use.The following has been provided by the initial reporter: this is a complaint about blood leak.A customer pointed out that there was blood leakage during blood collection with the push button (21g) of the winged needle.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information.D10: device available for evaluation: yes.D10: returned to manufacturer on: 30-oct-2023.H.6.Investigation summary: material #: 367326.Lot/batch #: 3102098.Bd received 3 samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for sliced / damaged tubing with the incident lot was observed.One of the samples exhibited tubing that had been cut through the seal of the package while the other two samples had nicks in the tubing.Additionally, 30 retention samples from bd inventory were evaluated by visual examination and functional draw testing and the issue of leakage / damaged tubing was not observed.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 from damaged tubing.Bd determined that the root cause of the sliced tubing was attributed to the tubing sticking out of the blister pack during packaging.A corrective action was taken to change the position of the wind-head to allow the product to better conform to the packaging.A root cause could not be determined for the samples exhibiting small nicks in the tubing.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• 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: 18093714
• Report Number: 1024879-2023-00796
• Device Sequence Number: 5993048
• Product Code: JKA
• UDI-Device Identifier: 50382903673266
• UDI-Public: (01)50382903673266
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: SEE H.10
• 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): 01/08/2024

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: 3102098
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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