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

Catalog Number 301746

Device Problems Break (1069); Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/04/2024

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, there was foreign matter found on three (3) devices, sleeve leakage seen with one (1) device, and loose cannulas on twenty-one (21) devices.No patient impact reported.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for evaluation: yes.D.9:device eval by manufacturer? yes.D9: returned to manufacturer on: 2024-january- 29th.H.6 investigation summary material #: 301746.Lot/batch #: 3085479.Bd received 54 samples and 1 photo for investigation.The photo was reviewed and the customer¿s indicated failure mode for foreign matter was observed.Additionally, the customer samples were evaluated by visual examination and the following observations were made.Three returned samples had a white foreign matter on their cannula.The material was analyzed by fourier transform infrared spectroscopy (ftir) and was determined to be polystyrene.One sample had a hooked needle point.One sample had a hole in its sleeve which could contribute to leakage.Functional leakage testing was performed on an additional 7 returned samples and no further defects relating to leakage were observed.Additionally, the returned samples were functionally tested by removing their non-patient shields and 22 samples were observed to have loose iv shields.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 modes foreign matter, hooked needle point, leakage, and loose iv shield.Bd has initiated further root cause investigation relating to the issues of foreign matter, hooked needle point, and loose iv shield through corrective and preventive actions.Bd was not able to identify a root cause for the leakage failure mode.

Event Description

It was reported that while using bd vacutainer® flashback blood collection needle, there was foreign matter found on three (3) devices, sleeve leakage seen with one (1) device, and loose cannulas on twenty-one (21) devices.No patient impact reported.

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19010700
• MDR Text Key: 339015839
• Report Number: 8041187-2024-00027
• 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: 04/02/2024

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: 3085479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2023
• 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