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

Catalog Number 367364

Device Problem Difficult or Delayed Activation (2577)

Patient Problem Pain (1994)

Event Date 09/19/2023

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: d.1 medical device type: fpa.D.2.Common device name: intravascular administration set.H.6 investigation summary: bd received 5 samples for investigation.The samples were evaluated by functional testing each having their safety feature activated, and the indicated failure mode retraction failure with the incident lot was not observed as all product specifications were met.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 is unable to be confirmed.Bd was not able to identify a root cause for the indicated failure mode.H3 other text: see h.10.

Event Description

It was reported that during use with bd vacutainer® ultratouch¿ push button blood collection set it was difficult to activate the safety feature.Patient experience pain but no other impact was reported.The following information was provided by the initial reporter: customer states product.After multiple attempts, push button is sticking or difficult to push resulting in patient pain.

• Brand Name: BD VACUTAINER® ULTRATOUCH¿ 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17935837
• MDR Text Key: 325690174
• Report Number: 1024879-2023-00703
• 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: K212724
• 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
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367364
• Device Lot Number: 3151169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2023
• 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