MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SERUM BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367812

Device Problem Defective Component (2292)

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

Event Date 08/18/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® serum blood collection tubes, the device experienced stopper creep out or loose closure.This event occurred 3000 times.The following information was provided by the initial reporter.The customer stated: phlebotomist observed the tube hemoguard cap was not fit properly.

Event Description

It was reported when using the bd vacutainer® serum blood collection tubes, the device experienced stopper creep out or loose closure.This event occurred (b)(4) times.The following information was provided by the initial reporter.The customer stated: phlebotomist observed the tube hemoguard cap was not fit properly additional information received: 05-sep-2022 - received an email: the customer observed the issue while using the same batch approx.(b)(4) devices.Same batch stocks returned by customer is (b)(4) units.

Manufacturer Narrative

The following fields have been updated with additional information: b.5.Describe event or problem: it was reported when using the bd vacutainer® serum blood collection tubes, the device experienced stopper creep out or loose closure.This event occurred (b)(4) times.The following information was provided by the initial reporter.The customer stated: phlebotomist observed the tube hemoguard cap was not fit properly additional information received: 05-sep-2022 - received an email: the customer observed the issue while using the same batch approx.(b)(4) devices.Same batch stocks returned by customer is (b)(4) units.D9: device available for evaluation: yes d9: returned to manufacturer on: 2022-09-13 h.6.Investigation summary: bd received 5 samples for investigation.The samples were evaluated by functional testing and the indicated failure mode for stopper creepout with the incident lot 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 stopper creepout.Bd has initiated further root cause investigation relating to the issue of stopper creepout through corrective and preventive actions.H3 other text : see h.10.

• Brand Name: BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15414739
• MDR Text Key: 300175401
• Report Number: 1024879-2022-00515
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903678129
• UDI-Public: 00382903678129
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: BK050036
• 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: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 367812
• Device Lot Number: 1293958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• 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