MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; SEE H.10

Catalog Number 367324

Device Problem Leak/Splash (1354)

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

Event Date 03/05/2024

Event Type  malfunction  

Event Description

It was reported that while using bd vacutainer® push button blood collection set, there was blood leakage from the winged needle during use.No patient impact reported.

Manufacturer Narrative

D.2.Medical device type: one additional code applies: jka.D2a: common device name: blood specimen collection device; intravascular administration set.E.1: initial reporter facility name: (b)(6).H.6.Investigation summary: "material #: 367324.Lot/batch #: 3032591.Bd received 1 sample and 1 photo for investigation.The sample and photo were reviewed and the customer¿s indicated failure mode for leakage was observed as the extension tubing is damaged.The extension tubing was caught in the packaging seal and a longitudinal breach was created in the tubing when the unit packaging was cut.The breach would have allowed fluid to leak from the extension tubing.Additionally, 50 retention samples from bd inventory were evaluated by visual examination, and another 12 by functional draw testing, and the issue of damaged tubing / leakage 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 damaged tubing.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.".

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: SEE H.10
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19007840
• MDR Text Key: 339142875
• Report Number: 1710034-2024-00265
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903673247
• UDI-Public: (01)00382903673247
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K220212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,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: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367324
• Device Lot Number: 3032591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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