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

Model Number 367338

Device Problem Volume Accuracy Problem (1675)

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

Event Date 10/27/2022

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.Date of event: unknown.The date received by manufacturer has been used for this field.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 there was insufficient blood flow through the device.The following information was provided by the initial reporter.The customer stated: "blood stopped flowing into tube for cat 367338 lot 1169911.The phlebotomist stated this was caused due to access issue to the vein.Per document, no patient adverse event to report.".

Manufacturer Narrative

H.6.Investigation summary: bd did not receive samples or photos from the customer in support of this complaint, therefore, 30 retention samples from the bd inventory were subjected to functional testing and the issue of insufficient blood was not observed.Therefore, this complaint cannot be confirmed based on retain sample testing results.As no customer samples or photos were received the scope of this investigation is limited.Bd is unable to confirm the customer reported failure mode of insufficient blood flow based on the retain sample testing analysis.Bd was unable to determine a root cause for the reported issue.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.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.

Event Description

It was reported when using the bd vacutainer® push button blood collection set there was insufficient blood flow through the device.The following information was provided by the initial reporter.The customer stated: "blood stopped flowing into tube for cat 367338 lot 1169911.The phlebotomist stated this was caused due to access issue to the vein.Per document, no patient adverse event to report.".

• 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
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15825361
• MDR Text Key: 303945104
• Report Number: 1024879-2022-00675
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673389
• UDI-Public: 50382903673389
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Model Number: 367338
• Device Catalogue Number: 367338
• Device Lot Number: 1169911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2021
• 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