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

Model Number 367342

Device Problems Leak/Splash (1354); Air/Gas in Device (4062)

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

Event Date 05/09/2023

Event Type  malfunction  

Event Description

It was reported that during use with an unspecified amount of bd vacutainer® push button blood collection set air bubble form in the tubing and blood leakage occurred.There was no patient impact.The following information was provided by the initial reporter: we have been noticing bubbles form in the line while still in the vein.-did exposure to blood or bf occur? every time the needle is retracted outside of the vein, there is splatter all over the place.We know we are supposed to lay a 2x2 over the needle prior to pushing the button, but have you tried to do that while bending over a patient bed and sticking a side arm vein? there is no way to lay the gauze on the patient's arm.No one has been splattered in the face, but drawing areas are being exposed to blood hazards.

Manufacturer Narrative

There were multiple medical device types reported to be involved.The information for the additional device type is as follows: medical device type: fpa.Common device name: intravascular administration set.Investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the blood can be seen on the wing of the device as well as the table.It was stated that the retraction was activated outside of the vein.The product circular states, "activation of the device while the needle is still in the venipuncture site is recommended." additionally, 30 retention samples from bd inventory were evaluated by functional draw testing and no issues were observed relating to air bubbles as all samples met specifications.Another 30 retention samples from bd inventory were evaluated by retraction lockout testing to assess splatter and no issues were observed relating to 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 air bubbles and splatter.Bd was not able to identify a root cause for the indicated failure modes.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17052228
• MDR Text Key: 316516322
• Report Number: 1024879-2023-00343
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673426
• UDI-Public: (01)50382903673426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030573
• 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
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 367342
• Device Catalogue Number: 367342
• Device Lot Number: 3061829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• 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