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

Catalog Number 365076

Device Problem Leak/Splash (1354)

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

Event Date 01/04/2024

Event Type  malfunction  

Event Description

It was reported that when using the bd vacutainer® flashback blood collection needle, blood started leaking out the hub of the needle during collection.No patient impact or injury reported.

Manufacturer Narrative

E.1.Initial reporter adder 1: (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.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for evaluation: yes d.9:deviceevalution by manufacturer? yes d9: returned to manufacturer on: 2024-january- 15th the following fields were updated due to additional information: d4.Medical device lot #: 3145997 d4.Medical device expiration date: 05/31/2025 h4.Device manufacture date: 06/16/2023 d.4 unique identifier (udi) (b)(4) h.6 investigation summary material #: 365076 lot/batch #: 3145997 bd received twelve unused samples from lot 3175392, one used sample from lot 3145997, and one photo for investigation.The photo was reviewed and the customer¿s indicated failure mode for leakage was observed.Additionally, the used customer sample was evaluated by visual examination and no defects were observed that could cause leakage.The 12 unused samples from lot 3175392 were evaluated by visual examination and functional testing and no issues were observed relating to leakage as all samples met specifications.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 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.H3 other text : see h.10.

Event Description

It was reported that when using the bd vacutainer® flashback blood collection needle, blood started leaking out the hub of the needle during collection.No patient impact or injury reported.

• Brand Name: BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• 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: 18579320
• MDR Text Key: 333726796
• Report Number: 8041187-2024-00007
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 50382903650762
• UDI-Public: (01)50382903650762
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Physician
• 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: Health Professional
• Device Catalogue Number: 365076
• Device Lot Number: 3145997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1