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

Catalog Number 301746

Device Problem Leak/Splash (1354)

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

Event Date 10/11/2023

Event Type  malfunction  

Manufacturer Narrative

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, the customer reported that one box of the recent batch of venous blood collection needles had two cases of blood leakage.The following information was provided by the initial reporter: on the afternoon of (b)(6) 2023, when visiting the blood collection room of the physical examination center, a blood collection nurse in the blood collection room, reported that one box of the recent batch of venous blood collection needles had two cases of blood leakage.As a result, the blood collection room is afraid to continue using the remaining needles in the box.

Event Description

It was reported that while using bd vacutainer® flashback blood collection needle, the customer reported that one box of the recent batch of venous blood collection needles had two cases of blood leakage.The following information was provided by the initial reporter: on the afternoon of (b)(6) 2023, when visiting the blood collection room of the physical examination center, a blood collection nurse in the blood collection room, reported that one box of the recent batch of venous blood collection needles had two cases of blood leakage.As a result, the blood collection room is afraid to continue using the remaining needles in the box.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but 4 photos were provided for investigation.The photos were reviewed and the indicated failure mode for sleeve leakage was 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 sleeve leakage.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.H3 other text : see h10.

• 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 ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18006683
• MDR Text Key: 326709614
• Report Number: 8041187-2023-00547
• 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: 11/20/2023

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: 3057809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• 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