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

Model Number 367815

Device Problems Device Ingredient or Reagent Problem (2910); Material Deformation (2976); Separation Problem (4043)

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

Event Date 12/04/2022

Event Type  malfunction  

Event Description

It was reported by the customer that red cell hang up and tube deformities were observed.Verbatim; referencing a photo sent to bd, that it is observed a tube in horizontal position showing its label.It looks like there are red cells on the top of tube in its wall.The tubes with these lot numbers mentioned have deformities in the upper part where the stopper is inserted, if you can see the images it is wider than the diameter of the tube.How many units of the product presented the reported deviation? a: we estimate one rack of 6.0 ml tubes.

Manufacturer Narrative

Date of event is unknown, the date received by manufacturer has been used for this field.(b)(6).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: b.5 describe event or problem: it was reported by the customer that red cell hang up and the stopper popping out of the tube were observed.Verbatim; referencing a photo sent to bd, that it is observed a tube in horizontal position showing its label.It looks like there are red cells on the top of tube in its wall.The tubes with these lot numbers mentioned have deformities in the upper part where the stopper is inserted, if you can see the images it is wider than the diameter of the tube.How many units of the product presented the reported deviation? a: we estimate one rack of 6.0 ml tubes.Annex a code: a1503 h.6.Investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for red cell hang -up, damaged, and stopper pop off 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.Further testing of retention samples could not be conducted as the tubes expired on 11/30/2022.This complaint has been confirmed for red cell hang-up, damage, and stopper pop-off; however, bd makes no claims on expired product and further testing could not be completed since the tubes expired 11/30/2022.Bd was not able to identify a root cause for the indicated failure mode red cell hang up and tube dimension.Bd has initiated further root cause investigation relating to the issue of stopper pop off through corrective and preventive actions.

Event Description

It was reported by the customer that red cell hang up and the stopper popping out of the tube were observed.Verbatim; referencing a photo sent to bd, that it is observed a tube in horizontal position showing its label.It looks like there are red cells on the top of tube in its wall.The tubes with these lot numbers mentioned have deformities in the upper part where the stopper is inserted, if you can see the images it is wider than the diameter of the tube.¿ how many units of the product presented the reported deviation? a: we estimate one rack of 6.0 ml tubes.

• 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: 16078059
• MDR Text Key: 308529614
• Report Number: 1024879-2022-00748
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

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 Expiration Date: 11/30/2022
• Device Model Number: 367815
• Device Catalogue Number: 367815
• Device Lot Number: 1176698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 02/14/2023
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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