MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; SEE H.10

Model Number	367326
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name: blood specimen collection device; intravascular administration set.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 bd vacutainer® push button blood collection set that the adapter cannot be inserted before blood collection.The following information was provided by the initial reporter the customer found that the adapter cannot be inserted before blood collection.Perhaps a part may be detached.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2023-05-16.H.6.Investigation summary: bd received 1 sample for investigation.The sample was evaluated by functional testing, attaching a luer adapter to the female luer of the device, and the indicated failure mode for unable to attach with the incident lot was not observed as all product specifications were met.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 unable to attach.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
Event or Problem Description
It was reported that while using bd vacutainer® push button blood collection set that the adapter cannot be inserted before blood collection.The following information was provided by the initial reporter the customer found that the adapter cannot be inserted before blood collection.Perhaps a part may be detached.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: SEE H.10
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16989238
• Report Number: 1024879-2023-00319
• Device Sequence Number: 6932109
• Product Code: JKA
• UDI-Device Identifier: 50382903673266
• UDI-Public: 50382903673266
• Combination Product (Y/N): N
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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: 02/29/2024
• Device Model Number: 367326
• Device Catalogue Number: 367326
• Device Lot Number: 2060270
• 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: 04/26/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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