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

Catalog Number 301746

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 03/05/2023

Event Type  malfunction  

Manufacturer Narrative

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 during use with bd vacutainer® flashback blood collection needle there was poor sleeve function and blood leakage occurred.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2023, the patient reported that a blood test was performed at hospital, and it was found that the needle sheath was not reset in the blood collection tube, causing blood to flow into the needle holder.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16632776
• MDR Text Key: 312411974
• Report Number: 8041187-2023-00124
• Device Sequence Number: 1
• Product Code: JKA
• 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
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301746
• Device Lot Number: 2207516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• 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