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

Catalog Number 367986

Device Problem Short Fill (1575)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd vacutainer® sst¿ blood collection tubes, there was no negative pressure and could not draw blood.The nurse could not draw blood so it was changed to a different tube before completing blood draw successfully.

Manufacturer Narrative

H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.E1: initial reporter facility name: (b)(6) hospital.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for underfill was observed.Additionally, 20 retention samples from bd inventory were were subjected to a draw test for low or no draw.All tubes were within specification.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 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 that while using the bd vacutainer® sst¿ blood collection tubes, there was no negative pressure and could not draw blood.The nurse could not draw blood so it was changed to a different tube before completing blood draw successfully.

• 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: 18155168
• MDR Text Key: 329618337
• Report Number: 1024879-2023-00832
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679862
• UDI-Public: (01)50382903679862
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/01/2023

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: Other
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 367986
• Device Lot Number: 3116899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2023
• 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