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

Catalog Number	367354
Medical Device Problem Code	Leak/Splash (1354)
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
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 was reported that while using bd vacutainer® push button blood collection set with pre-attached holder, blood splattered out the iv needle end when the safety feature was activated.Blood got on the patient and on the health professional.The health professional was wearing gloves.The measures taken were to spray and wash the affected site.Four other health professionals experienced this issue.
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: 19-dec-2023.H.6.Investigation summary: material #: 367354.Lot/batch #: 3053931.Bd received 8 shelf packs of samples for investigation.Thirty (30) of the samples were chosen at random and evaluated by functional testing and the indicated failure mode for splatter 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 splatter.Bd was not able to identify a root cause for the indicated failure mode.
Event or Problem Description
It was reported that while using bd vacutainer® push button blood collection set with pre-attached holder, blood splattered out the iv needle end when the safety feature was activated.Blood got on the patient and on the health professional.The health professional was wearing gloves.The measures taken were to spray and wash the affected site.Four other health professionals experienced this issue.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
• 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: 18339647
• Report Number: 1024879-2023-00910
• Device Sequence Number: 6739963
• Product Code: FPA
• UDI-Device Identifier: 00382903673544
• UDI-Public: (01)00382903673544
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K011984
• 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): 01/04/2024

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: Health Professional
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: 367354
• Device Lot Number: 3053931
• 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: 11/28/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2023
• 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