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

Catalog Number 367815

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 05/18/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® serum blood collection tubes, the device experienced incorrect additive.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that noticed "spray" or additive in tubes.Spoke with the customer and explained that the tubes do contain an additive.(clot activator).These vacutainer tubes, catalog 367815, red top serum tubes do contain an additive - the spray coated particles that you see are the clot activator, which is essential in facilitating the clotting process of the blood.This appearance in the tubes is perfectly normal.Customer problem 367815 contains "some type of spray inside the tubes" steps taken with customer/troubleshooting: called and left a vm that the "spray" is the clot activator, and is supposed to be there.I also sent an email with the same information.

Manufacturer Narrative

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

Manufacturer Narrative

H6: investigation summary bd sumter received 2 customer photos for review and analysis.The photos were evaluated and confirm the reported issue of additive abnormality in the tubes.Therefore, this complaint is confirmed.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Bd was able to confirm the customer¿s reported failure mode with the photos provided by the customer.The root cause of the additive abnormality is attributed to the manufacturing process.

Event Description

It was reported when using the bd vacutainer® serum blood collection tubes, the device experienced incorrect additive.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that noticed "spray" or additive in tubes.Spoke with the customer and explained that the tubes do contain an additive.(clot activator) these vacutainer tubes, catalog 367815, red top serum tubes do contain an additive - the spray coated particles that you see are the clot activator, which is essential in facilitating the clotting process of the blood.This appearance in the tubes is perfectly normal.Customer problem 367815 contains "some type of spray inside the tubes" steps taken with customer/troubleshooting: called and left a vm that the "spray" is the clot activator, and is supposed to be there.I also sent an email with the same information.

• 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: 14634442
• MDR Text Key: 295809699
• Report Number: 1024879-2022-00296
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903678150
• UDI-Public: 00382903678150
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• 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: 367815
• Device Lot Number: 1272894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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