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 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: material no.367968 lot no.1036265.Bd received 163 samples and 17 photos for investigation.The photos and samples were evaluated by visual examination and the customer¿s indicated failure mode for ' foreign matter (fm) in gel, embedded fm in tube and hemogard, ink smear (dirty tube), printing defect, and bubbles in gel' with the incident lot was observed.Bd determined that the root cause of the indicated failure mode was attributed to: the black fm in the tube appears to be a piece of burnt silica.The root cause of the white fm in the gel would be 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.The fm embedded in the tube and hemogard shield occurred during the injection molding start-up process with inadequate purging of the line.The ink smear and defective marking/printing on the tubes is caused by a felt pad used for ink application dislodging from the labeling equipment.An incomplete line clearance did not cull all affected tubes.Based on the investigation results, gel air bubbles may occur in tubes when inadequate purging occurs during gel drum changes.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.Bd has initiated further root cause investigation relating to the issue of ' foreign matter (fm) in gel, embedded fm in tube and hemogard, ink smear (dirty tube), printing defect, and bubbles in gel' through corrective and preventive actions.(capa #2201538) our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported when using the bd vacutainer® sst¿ blood collection tubes, the user identified the following issues: foreign matter in tube; biological and non-biological , no label or missing label information ( all packaging levels) , and air bubbles in the tube gel.The following issues were found in tubes: air bubbles ×104, fm in gel x13, defective marking x41, dirty cap ×1, spot in tube ×2, dirty tube ×2.

• 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
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11935101
• MDR Text Key: 256476518
• Report Number: 1024879-2021-00357
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 367968
• Device Lot Number: 1036265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2021
• 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