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

Catalog Number 367985

Device Problems Fracture (1260); Short Fill (1575); Device Ingredient or Reagent Problem (2910); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

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

Event Date 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date of event is unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® sst¿ blood collection tubes that the user experienced several failures that included cracked and/or broken product or components of the product, underfill, poor barrier separation, and observed foreign matter no health impact or consequence reported.

Manufacturer Narrative

The following fields were updated: d9: device available for evaluation? yes.Returned to manufacturer on: 14-dec-2023.H6: investigation summary: bd received 106 samples and 13 photos for investigation.The photos were reviewed and the indicated failure mode for hole in the product/component, poor barrier separation, collapsed, cracked product/component, and underfill was observed, however foreign matter was not observed.Additionally, the customer samples along with retention samples from bd inventory, were evaluated by visual examination and functional testing.30 customer samples were randomly selected and subjected to a visual inspection for fm.1 of 30 customer samples failed.30 customer samples were randomly selected and subjected to a visual inspection for damaged product/component (hole in the product/component and cracked product/component).0 of 30 customer samples failed.30 customer samples were randomly selected and subjected to a visual inspection for collapsed.9 of 30 customer samples failed.10 customer samples were randomly selected and subjected to a brittleness test.5 of 10 customer samples failed.20 customer samples were subjected to a draw test for low or no draw.All tubes were within specification.30 customer samples were randomly selected and subjected to a visual inspection for gel air bubbles.7 of 30 customer samples failed.There were no difficulties encountered during blood collection and all tubes exhibited proper fill.Bd was unable to duplicate the customer¿s indicated failure mode (poor barrier separation) because the defect was not evident in the testing of the complaint lot samples.All visual observations of both retention and control samples tested demonstrated clinically acceptable performance.All tubes performed as expected.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 hole in the product/component, poor barrier separation, collapsed, cracked product/component, gel air bubbles, foreign matter and underfill.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 when using the bd vacutainer® sst¿ blood collection tubes that the user experienced several failures that included cracked and/or broken product or components of the product, underfill, poor barrier separation, and observed foreign matter no health impact or consequence reported.

• Brand Name: BD VACUTAINER® SST¿ 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18186841
• MDR Text Key: 329804494
• Report Number: 1024879-2023-00843
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679855
• UDI-Public: (01)50382903679855
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 367985
• Device Lot Number: 3093363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2023
• 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