MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE

Catalog Number 301746

Device Problems Leak/Splash (1354); Product Quality Problem (1506); Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

E.1.Initial reporter phone #: (b)(6).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 Description

It was reported that while using bd vacutainer® flashback blood collection needle, there were 50 needles with loose tips, 4 with blood leaks, and 9 with foreign objects on the tips.No exposure to blood or patient impact reported.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for evaluation: yes.D.9:device eval by manufacturer? yes.D9: returned to manufacturer on: 03/22/2024.H.6 investigation summary: material #: 301746.Lot/batch #: 3109100.Bd received 24 samples and 1 photo for investigation.The photo was reviewed and the customer¿s indicated failure mode for foreign matter was observed.Additionally, the customer samples were evaluated by visual examination and functional testing and the following observations were made.Two samples were found with foreign matter on their cannula.The foreign matter was analyzed by fourier transform infrared spectroscopy (ftir) analysis and was determined to be polyethylene terephthalate and polystyrene.Three samples had hooked cannula points.Three samples had loose iv shields.None of the samples leaked during functional testing.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 modes foreign matter, hooked needle point, and loose iv shield.This complaint could not be confirmed for leakage.Bd has initiated further root cause investigation relating to the issues of foreign matter, needle point integrity, and loose iv shield through corrective and preventive actions.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.".

Event Description

It was reported that while using bd vacutainer® flashback blood collection needle, there were 50 needles with loose tips, 4 with blood leaks, and 9 with foreign objects on the tips.No exposure to blood or patient impact reported.

• Brand Name: BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE
• Type of Device: BLOOD COLLECTION NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18584316
• MDR Text Key: 334783047
• Report Number: 8041187-2024-00008
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903017462
• UDI-Public: (01)30382903017462
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• 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,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301746
• Device Lot Number: 3109100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2023
• 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