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

Catalog Number 367365

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 09/27/2023

Event Type  malfunction  

Event Description

It was reported that while using bd vacutainer® ultratouch¿ push button blood collection set it was difficult to activate safety feature.Event occured 2 times.The following was reported by the initial reporter: it was reported by the customer that push button did not activate to safety needle in guard.Customer is reporting push button did not activate to safetly needle in guard.Has happened twice within the last month.Affected lot number 2293206.

Manufacturer Narrative

D.2.Medical device type: jka.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

H.6.Investigation summary: material #: 367365.Lot/batch #: 2293206.Bd had not received samples or photos for evaluation.Therefore, 30 retention samples from bd inventory were evaluated by functional testing, each having their safety feature activated, and the issue relating to unable to retract was observed in one wingset.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.This complaint has been confirmed for the indicated failure mode unable to retract.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported that while using bd vacutainer® ultratouch¿ push button blood collection set it was difficult to activate safety feature.Event occured 2 times.The following was reported by the initial reporter: it was reported by the customer that push button did not activate to safety needle in guard.Customer is reporting push button did not activate to safetly needle in guard.Has happened twice within the last month.Affected lot number 2293206.

• Brand Name: BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 18029783
• MDR Text Key: 326854132
• Report Number: 1024879-2023-00771
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50382903673655
• UDI-Public: 50382903673655
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K212724
• 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: 01/24/2024

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 Catalogue Number: 367365
• Device Lot Number: 2293206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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