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

Catalog Number 367986

Device Problem Air/Gas in Device (4062)

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

Event Date 06/30/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd vacutainer® sst¿ blood collection tubes that there was air bubbles in gel.The following information was provided by the initial reporter: defect: there are air bubbles in the separating gel in the tube; quantity: 297 pieces (the number of unopened products, you can see that there are bubbles in the separating glue in the tube).Impact: no adverse effects on patients and medical staff.

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

The following fields have been updated with additional information: h.3.If other specify.H.4.Device manufacture date: 01-aug-2023.H.6.Investigation summary: two customer photos and 10 customer samples were received for review and analysis.Photo review: after review and analysis, a gel airbubble is shown at the bottom of the tube in the second photo.Returned sample review: ten customer samples were subjected to a visual inspection for gel airbubbles.10 of 10 customer samples failed visual inspection.Retention sample review: 30 retain samples were subjected to a visual inspection for gel airbubbles.1 of 30 retain samples failed visual inspection.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.This complaint has been confirmed for gel air bubbles.Bd has not identified a root cause.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for monitoring of current trends.

Event Description

It was reported that while using the bd vacutainer® sst¿ blood collection tubes that there was air bubbles in gel.The following information was provided by the initial reporter: defect: there are air bubbles in the separating gel in the tube.Quantity: (b)(4) pieces.Impact: no adverse effects on patients and medical staff.

• 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: 17411177
• MDR Text Key: 320230027
• Report Number: 1024879-2023-00498
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679862
• UDI-Public: 50382903679862
• 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
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 367986
• Device Lot Number: 2258774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2022
• 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