MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES; TUBE SST PLH 13X100MM 5.0ML SLBL GOLD

Catalog Number 367989

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 07/19/2023

Event Type  malfunction  

Event Description

It was reported that customer used bd vacutainer® sst¿ blood collection tubes after the expiration date.This event occurred 1time and no patient impact.The following information was provided by the initial reporter: customer states lot # is unknown.Customer has decided to dispose of tubes.Per customer: the sst was used in a kit for a clinical study ¿ built by labcorp central labs.Customer reports a tube with exp date 30-jun-2023, was used to collect a blood sample on (b)(6) 2023.

Manufacturer Narrative

D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Bd makes no claims on expired product.Complaints received for this device and reported condition will continue to be tracked and trended.H3 other text : see h.10.

Event Description

It was reported that customer used bd vacutainer® sst¿ blood collection tubes after the expiration date.This event occurred 1time and no patient impact.The following information was provided by the initial reporter: customer states lot # is unknown.Customer has decided to dispose of tubes.Per customer: the sst was used in a kit for a clinical study ¿ built by labcorp central labs.Customer reports a tube with exp date (b)(6) 2023, was used to collect a blood sample on (b)(6) 2023.

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
• Type of Device: TUBE SST PLH 13X100MM 5.0ML SLBL GOLD
• 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: 18103781
• MDR Text Key: 327755039
• Report Number: 1024879-2023-00803
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679893
• UDI-Public: (01)50382903679893
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367989
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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