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

Catalog Number 301746

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/12/2023

Event Type  malfunction  

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that prior to use with the bd vacutainer® flashback blood collection needle, the needle fell off.This occurred 8 times.The following information was provided by the initial reporter, translated from chinese: stage: when opening the package.Defect: the needle fell off after the needle was pulled out.Quantity: since october 10th, an average of 8 problems have occurred every day, with a total of about 40.Impact: no impact on patients or users.

Manufacturer Narrative

H.6.Investigation summary: material #: 301746.Lot/batch #: 3109102.Bd had not received samples or photos for evaluation.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 mode loose iv shield.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.Our business team regularly reviews the collected data for identification of emerging trends.".

Event Description

It was reported that prior to use with the bd vacutainer® flashback blood collection needle, the needle fell off.This occurred 8 times.The following information was provided by the initial reporter, translated from chinese: stage: when opening the package.Defect: the needle fell off after the needle was pulled out.Quantity: since october 10th, an average of 8 problems have occurred every day, with a total of about 40.Impact: no impact on patients or users.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 18007135
• MDR Text Key: 326585581
• Report Number: 8041187-2023-00549
• Device Sequence Number: 1
• Product Code: JKA
• 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: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301746
• Device Lot Number: 3109102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2023
• 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