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

Catalog Number 367812

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 01/30/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® serum blood collection tubes, the device experienced stopper creep out/ loose closure.This event occurred 10,000 times.The following information was provided by the initial reporter.The customer stated: customer noticed that the tube cap was not fit, it is very loose on the tube and often falls down.The circumstances that they have had this issue while sampling collection, centrifugation, and sample processing.Due to these issues, they had faced accidents a few times dropping the tubes and lost the serum and whole blood which leads to asking for a repeat sample from the patients and it affects our turnaround time.

Manufacturer Narrative

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

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 07-mar-2022.H.6.Investigation: bd received five (5) samples and one (1) video for investigation.The video was reviewed and the indicated failure mode for decapping was observed, as it shows the tube assembly being held by the hemogard shield and the tube falling out of the hemogard shield as it becomes unattached.Additionally, the customer samples were evaluated by functional testing and the indicated failure mode for decapping 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 notifications.This complaint has been confirmed for the indicated failure mode of decapping based on the returned sample testing and video.Bd has initiated further root cause investigation relating to the issue of stopper function defects through capa#1875009.

Event Description

It was reported when using the bd vacutainer® serum blood collection tubes, the device experienced stopper creep out/ loose closure.This event occurred 10,000 times.The following information was provided by the initial reporter.The customer stated: customer noticed that the tube cap was not fit, it is very loose on the tube and often falls down.The circumstances that they have had this issue while sampling collection, centrifugation, and sample processing.Due to these issues, they had faced accidents a few times dropping the tubes and lost the serum and whole blood which leads to asking for a repeat sample from the patients and it affects our turnaround time.

• 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: 13476882
• MDR Text Key: 286265676
• Report Number: 1024879-2022-00068
• 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: 04/12/2022

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 Expiration Date: 07/31/2022
• Device Catalogue Number: 367812
• Device Lot Number: 1081112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 04/12/2022
• Supplement Dates FDA Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2021
• 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