MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367344

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 11/07/2023

Event Type  malfunction  

Event Description

It was reported that after inserting the bd vacutainer® push button blood collection set into the patient's arm, the operator was unable to insert the tube due to a defect in the adapter needle, causing a blood leak.

Manufacturer Narrative

There were multiple 510k numbers reported to be involved.The information is as follows: g.5.Pma / 510(k)#: k220212.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

H.6.Investigation summary: bd had not received samples, but 6 photos were provided for investigation.The photos were reviewed and the indicated failure mode for cracked luer adapter was observed.Additionally, 10 retention samples from bd inventory were evaluated by visual examination and the issue of cracked luer adapter was not 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 cracked luer adapter.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.".

Event Description

It was reported that after inserting the bd vacutainer® push button blood collection set into the patient's arm, the operator was unable to insert the tube due to a defect in the adapter needle, causing a blood leak.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18249086
• MDR Text Key: 330567913
• Report Number: 9617032-2023-01714
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50382903673440
• UDI-Public: (01)50382903673440
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K030573
• 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: 12/04/2023

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: Health Professional
• Device Catalogue Number: 367344
• Device Lot Number: 3060880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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