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

Catalog Number 301746

Device Problem Filling Problem (1233)

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

Event Date 11/17/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: "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 insufficient blood flow.".

Event Description

It was reported when using the bd vacutainer® flashback blood collection needle was not enough, which resulted in slow bleeding and insufficient blood collection.The following information was provided by the initial reporter.The customer stated: "the nurse found that the negative pressure of the one-time venous blood collection needle was not enough, resulting in slow bleeding and insufficient blood collection.The nurse replaced the new two-way needle in time without affecting the patient.".

• 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 ; 8015296192
• MDR Report Key: 16056622
• MDR Text Key: 308448010
• Report Number: 8041187-2022-00771
• 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: 12/16/2022

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 301746
• Device Lot Number: 2056710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• 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