MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367324

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

There were multiple medical device types reported to be involved.The information for the additional device type is as follows: medical device type: fpa.Common device name: intravascular administration set.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® push button blood collection set, the device experienced foreign matter on device cannula/ needle / tubing.The following information was provided by the initial reporter.The customer stated: this is a report about fm in the package of wingset pbbcs.According to the customer's report, something like dust (two pieces of cardboard) was found in the package.

Event Description

It was reported when using the bd vacutainer® push button blood collection set, the device experienced foreign matter on device cannula/ needle / tubing.The following information was provided by the initial reporter.The customer stated: this is a report about fm in the package of wingset pbbcs.According to the customer's report, something like dust (two pieces of cardboard) was found in the package.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-08-24.H6: investigation summary: bd received 1 sample and 6 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for foreign matter was observed.Additionally, the customer samples were evaluated by visual examination and the indicated failure mode for foreign matter with the incident lot was 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.Bd determined that the root cause of the indicated failure mode was attributed to excessive adhesive solution buildup during the manufacturing process.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.H3 other text : see h10.

• Brand Name: BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 12320260
• MDR Text Key: 266475593
• Report Number: 1024879-2021-00582
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673242
• UDI-Public: 50382903673242
• Combination Product (y/n): N
• PMA/PMN Number: K030573
• 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: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Model Number: 367324
• Device Catalogue Number: 367324
• Device Lot Number: 1078501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 09/16/2021
• Supplement Dates FDA Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1