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

Catalog Number 367983

Device Problems Short Fill (1575); Contamination of Device Ingredient or Reagent (2901); Device Ingredient or Reagent Problem (2910); Device Contamination with Chemical or Other Material (2944); Material Twisted/Bent (2981)

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

Event Date 08/31/2023

Event Type  malfunction  

Event Description

It was reported that while using bd vacutainer® sst¿ blood collection tubes that there was a broken cap/underfill or low draw of a tube with blood/air bubbles in gel /foreign matter/abnormal additive form.The following information was provided by the initial reporter: stage: after opening the outer packaging.Defect: found after opening the outer packaging.Pipe cap deformation 2 pieces.Insufficient negative pressure due to bending and deformation of caps 6 pieces.There are large air bubbles in the separating gel 40 pieces.Red rubber deformed inside the cap 2 pieces.There are foreign objects in the separation gel 4 sticks.Labels are wrinkled and damaged 2.The coagulant is agglomerated and there are white foreign matter on the tube wall 7 pieces.No negative pressure 6 pieces.Quantity: 69 pieces in total.

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: bd had not received samples, but ten (10) photos were provided for investigation.Ten customer photos were received for review and analysis.After review and analysis of the customer photos, gel airbubbles can be seen in the third photo, improper assembly can be seen in the fifth photo, fm-unknown can be seen in the sixth photo, fm-nonbiologic can be seen in the seventh photo, label lift can be seen in the eighth photo, additive abnormality (additive rundown) can be seen in the ninth photo, and defective product/component can be seen on the hemogard shield in the tenth photo.Based on the review of the photos, bd is able to confirm defective product/component, gel airbubbles, improper assembly, fm-unknown, label lift, and additive abnormality.However, bd is unable to confirm underfill from the customer returned photos.Additionally, 30 retain samples were subject to a visual inspection for damaged components, gel airbubbles, improper assembly, label lift, additive abnormality, and fm.0 of 30 retain samples failed visual inspection.Twenty (20) retain samples were subjected to a draw test for low or no draw.All tubes were within specification.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.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 while using bd vacutainer® sst¿ blood collection tubes that there was a broken cap/underfill or low draw of a tube with blood/air bubbles in gel /foreign matter/abnormal additive form.The following information was provided by the initial reporter: stage: after opening the outer packaging.Defect: found after opening the outer packaging, pipe cap deformation 2 pieces, insufficient negative pressure due to bending and deformation of caps 6 pieces, there are large air bubbles in the separating gel 40 pieces, red rubber deformed inside the cap 2 pieces, there are foreign objects in the separation gel 4 sticks, labels are wrinkled and damaged 2, the coagulant is agglomerated and there are white foreign matter on the tube wall 7 pieces, no negative pressure 6 pieces.Quantity: 69 pieces in total.

Manufacturer Narrative

The following codes were added for the reported issue of underfill: imdrf annex d grid 1: d14 - no problem detected.Imdrf annex c grid 1: c19 - no device problem found.H.6.Investigation summary: bd had not received samples, but 10 photos were provided for investigation.The photos were reviewed and the indicated failure modes for gel air bubbles, improper assembly, foreign matter (fm) unknown, fm-non-biologic, label lift, additive abnormality, and defective product (defective shield) can be observed.Underfill was not observed.Additionally, 30 retention samples from bd inventory were visually inspected with no issues identified.20 retention samples were draw tested for low or no draw.All tubes were within specification.Complaints for sample quality are under statistical control for the month of august 2023.At this time, further testing is not indicated.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 gel airbubbles, improper assembly, foreign matter (fm) unknown, fm-non-biologic, label lift, additive abnormality, and defective product (defective shield) based on the photos provided.This complaint was unable to be confirmed for underfill.Bd was not able to identify a root cause for the indicated failure mode.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.Bd quality will continue to monitor sample quality complaints.

Event Description

It was reported that while using bd vacutainer® sst¿ blood collection tubes that there was a broken cap/underfill or low draw of a tube with blood/air bubbles in gel /foreign matter/abnormal additive form.The following information was provided by the initial reporter: stage: after opening the outer packaging defect: found after opening the outer packaging pipe cap deformation 2 pieces.Insufficient negative pressure due to bending and deformation of caps 6 pieces there are large air bubbles in the separating gel 40 pieces.Red rubber deformed inside the cap 2 pieces.There are foreign objects in the separation gel 4 sticks.Labels are wrinkled and damaged 2.The coagulant is agglomerated and there are white foreign matter on the tube wall 7 pieces.No negative pressure 6 pieces.Quantity: 69 pieces in total.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17782616
• MDR Text Key: 323854876
• Report Number: 1024879-2023-00632
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 367983
• Device Lot Number: 3067281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2023
• 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