BECTON, DICKINSON & CO., (BD) BD VACUTAINER SST BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
|
Back to Search Results |
|
Catalog Number 367968 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Contamination with Chemical or Other Material (2944); Illegible Information (4050)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/02/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
|
|
Event Description
|
It was reported that 28 bd vacutainer® sst¿ blood collection tubes had air bubbles, 4 contained foreign matter, and 4 had incorrect label information.The following information was provided by the initial reporter: "air bubbles ×28, fm in gel x3, damaged tube x2, defective marking x4, spot in tube x1.".
|
|
Manufacturer Narrative
|
H6: investigation summary bd received nineteen (19) samples and five (5) photos for investigation.The samples and photos were reviewed and the customer¿s indicated failure modes for gel bubble, foreign matter (fm), embedded fm, damaged tube, 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 gel bubble, foreign matter (fm), embedded fm, damaged tube, and defective marking.Bd was able to determine the root causes associated with the failure modes as: 1.The black fm in the tube 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.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.3.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.4.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.5.The embedded fm in the tube occurred during the injection molding start-up process.There was an inadequate purging of the line.Bd has initiated further root cause investigation relating to the issues of gel bubble, foreign matter (fm), embedded fm, damaged tube, 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.
|
|
Event Description
|
It was reported that 28 bd vacutainer® sst¿ blood collection tubes had air bubbles, 4 contained foreign matter, and 4 had incorrect label information.The following information was provided by the initial reporter: " air bubbles ×28.Fm in gel x3.Damaged tube x2.Defective marking x4.Spot in tube x1".
|
|
Search Alerts/Recalls
|
|
|