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 07/20/2021

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, air bubbles in gel.The following information was provided by the initial reporter.The customer stated: "the following issues were found in tubes: dirty tube x35, foreign matter in the gel x13, defective marking x19, dirty cap x1, air bubbles x12.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 8/27/2021 h.6.Investigation: bd received eighty-two (82) samples and nine (9) photos for investigation.The samples and photos were reviewed and the customer¿s indicated failure modes for foreign matter (fm), damaged tube, defective marking, gel air bubble, and embedded fm were observed.Bd was able to determine the root causes associated with the failure modes as: 1.The black fm in the tube is attributed to burnt silica.The white fm in the gel is attributed to inadequate mixing of material used in the gel manufacturing process.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 scratched tube is attributed to an equipment jam prior to the tube evacuation process.There was incomplete purging of tubes affected by the jam.3.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.4.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.5.The embedded fm in the hemogard cap occurred during the injection molding start-up process.There was an inadequate purging of the line.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), damaged tube, defective marking, gel air bubble, and embedded fm.Bd has initiated further root cause investigation relating to the issue of foreign matter (fm), damaged tube, defective marking, gel air bubble, and embedded fm through capa#2201538.H3 other text : see h.10.

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, air bubbles in gel.The following information was provided by the initial reporter.The customer stated: "the following issues were found in tubes: dirty tube x35 foreign matter in the gel x13 defective marking x19 dirty cap x1 air bubbles x12.".

• 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: 12324903
• MDR Text Key: 266669051
• Report Number: 1024879-2021-00586
• 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: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• 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: 08/27/2021
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1