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

Catalog Number 367344

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

Event Description

It was reported that while using bd vacutainer® push button blood collection set that there was a hole in the tubing causing blood to leak and when retracting the needle blood would splatter onto staff and the patient.No further information about exposure or impact was reported.

Manufacturer Narrative

D2a: common device name: blood specimen collection device; intravascular administration set.D2b: medical device type: jka, fpa h.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary material #: 367344 lot/batch #: 3317455 bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure modes for leakage and splatter with the incident lot were not observed.Additionally, 30 retention samples from bd inventory were evaluated by functional draw testing and no issues were observed relating to leakage or splatter as all samples met specifications.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 modes leakage and splatter.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.

Event Description

It was reported that while using bd vacutainer® push button blood collection set that there was a hole in the tubing causing blood to leak and when retracting the needle blood would splatter onto staff and the patient.No further information about exposure or impact was reported.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19033225
• MDR Text Key: 339255929
• Report Number: 1024879-2024-00310
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903673445
• UDI-Public: (01)00382903673445
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

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
• Device Operator: Other
• Device Catalogue Number: 367344
• Device Lot Number: 3317455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1