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

Catalog Number 367364

Device Problem Insufficient Information (3190)

Patient Problem Exposure to Body Fluids (1745)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that a phlebotomist received a dirty needle stick after using a bd vacutainer® ultratouch¿ push button blood collection set.The phlebotomist has post-exposure lab work.

Manufacturer Narrative

Investigation summary: bd received samples from the customer facility for investigation.The samples were draw tested with bd vacutainer tubes and following filling of the tubes, the safety push button was activated.All samples activated correctly with the iv needle retracting completely while remaining safely locked within the needle housing.Therefore, the product met all required specifications.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: based on evaluation of the customer samples, the customer¿s indicated failure mode for a non-retracted iv needle during activation of the safety push button with the incident lot was not observed as all samples met the required specifications.Root cause description: based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD COLLECTION SET
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7352626
• MDR Text Key: 102887236
• Report Number: 1024879-2018-00082
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673648
• UDI-Public: 50382903673648
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Phlebotomist
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 367364
• Device Lot Number: 7283699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention