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

Model Number 367342

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

There were multiple medical device types reported to be involved.The information for each 510(k) number is as follows: common device name: intravascular administration set.Medical device type: fpa.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 holder will not detach from the device.The following information was provided by the initial reporter.It was reported that bd vacutainer push button is not able to be disconnected at one of the needle site." per email: "bd vacutainer push button is not able to be disconnected at one of the needle site.There is an increase risk for needle stick as this part needs to be disconnected to attach to syringe.".

Event Description

It was reported when using the bd vacutainer® push button blood collection set the holder will not detach from the device.The following information was provided by the initial reporter.It was reported that bd vacutainer push button is not able to be disconnected at one of the needle site." per email: "bd vacutainer push button is not able to be disconnected at one of the needle site.There is an increase risk for needle stick as this part needs to be disconnected to attach to syringe.".

Manufacturer Narrative

H6: investigation summary bd received 1 needle from the customer in support of this complaint.An evaluation of the returned sample was conducted and the indicated failure mode of a misshaped protector was observed.Additionally, 30 retained samples from the d inventory were evaluated and no issues relating to the customer's alleged failure were identified however, the supplier has been notified about this incident.Bd was not able to identify a root cause, because this defect is a supplier issue.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.See h10.

• Brand Name: BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 11838593
• MDR Text Key: 266187871
• Report Number: 9617032-2021-00452
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673426
• UDI-Public: 50382903673426
• 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: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: 367342
• Device Catalogue Number: 367342
• Device Lot Number: 0288481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1