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 367352

Device Problem Leak/Splash (1354)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

It was reported that while using the bd vacutainer® push button blood collection set with pre-attached holder that blood is leaking during blood collection.No patient impact.

Manufacturer Narrative

D2b: medical device type: jka h.6.Investigation summary: "material #: 367352 lot/batch #: 3292564 bd received 1 sample and 1 photo for investigation.The photo was reviewed and the customer¿s indicated failure mode for leakage was observed.Additionally, the customer sample along with 30 retention samples from bd inventory were evaluated by functional draw testing and the indicated failure mode for leakage with the incident lot 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.Bd determined that the root cause of the indicated failure mode was attributed to the tubing being cut slightly too long to fit securely in the unit blister.The tubing length was shortened which corrected the issue.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends." h3 other text : see h.10.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18990497
• MDR Text Key: 339019305
• Report Number: 1024879-2024-00266
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903673520
• UDI-Public: (01)00382903673520
• 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
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367352
• Device Lot Number: 3292564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2023
• 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