MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367955

Device Problems Illegible Information (4050); Missing Information (4053)

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

Event Date 07/06/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes device experienced missing label information.This event occurred five times.The following information was provided by the initial reporter.The customer stated: customers open the packaging units, some tubes have no paper label at all, some tubes have two paper labels.

Manufacturer Narrative

Supplemental: the following fields have been updated: d.9 device available for eval? yes returned to manufacturer on - 08/17/2022 h.6 investigation summary bd received three (3) samples for investigation.The samples were evaluated by visual examination and the indicated failure modes for missing label and excess label with the incident lot was observed.Two tubes had no label and one tube had two labels.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to missing label or excess label as all samples met specifications.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 modes of missing label and excess label.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes device experienced missing label information.This event occurred five times.The following information was provided by the initial reporter.The customer stated: customers open the packaging units, some tubes have no paper label at all, some tubes have two paper labels.

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15165532
• MDR Text Key: 301944135
• Report Number: 9617032-2022-00700
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903679553
• UDI-Public: 00382903679553
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 367955
• Device Lot Number: 2123430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2022
• 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