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

Catalog Number 367968

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Contamination with Chemical or Other Material (2944); Unclear Information (4052)

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

Event Date 07/13/2021

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¿ blood collection tubes there was foreign matter in tube biological non-biological, no label /missing label information and air bubbles in the gel.The following information was provided by the initial reporter.The customer stated: "the following issues were found in the tubes: defective marking x21 foreign matter in the gel x10 dirty tube x20 air bubbles x15.".

Event Description

It was reported when using the bd vacutainer® sst¿ blood collection tubes there was foreign matter in tube biological non-biological, no label /missing label information and air bubbles in the gel.The following information was provided by the initial reporter.The customer stated: "the following issues were found in the tubes: defective marking x21.Foreign matter in the gel x10.Dirty tube x20.Air bubbles x15.".

Manufacturer Narrative

H6: investigation summary: bd received sixty-six (66) samples and five (5) photos for investigation.The samples and photos were reviewed and the customer¿s indicated failure modes for foreign matter (fm), gel bubble, and defective marking were 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.This complaint has been confirmed for the indicated failure modes of foreign matter (fm), gel bubble, and defective marking.Bd was able to determine the root causes associated with the failure modes as: 1.The black fm in the gel appears to be loose dirt.Inadequate purging of the line resulted in further processing of the tube.Additional housekeeping has been implemented in the tubes operation to mitigate foreign matter.Modifications have been made to the manufacturing line to catch loose fm to help mitigate this defect.2.The defective marking/printing on the tubes is attributed to a felt pad used for ink application dislodging from the labeling equipment.An incomplete line clearance did not cull all affected tubes.3.Gel air bubbles is attributed to introduction of air and inadequate purging during gel drum changes.Tool was implemented at the gel dispense area to help aid in identifying and eliminating gel defects.Bd has initiated further root cause investigation relating to the issues of foreign matter (fm), gel bubble, and defective marking through corrective and preventive actions.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.H3 other text : see h10.

• 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
• MDR Report Key: 12294693
• MDR Text Key: 265614734
• Report Number: 1024879-2021-00563
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

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: 04/30/2022
• Device Catalogue Number: 367968
• Device Lot Number: 1102078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 08/30/2021
• Supplement Dates FDA Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1