MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON SET; INTRAVASCULAR ADMINISTRATION SET

Model Number 367364

Device Problems Difficult or Delayed Activation (2577); Material Twisted/Bent (2981)

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

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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® ultratouch¿ push button blood collection set that it was kinked and tubing with buttons that are difficult to push.The following information was provided by the initial reporter.The customer stated: "according to the customer's report, there were products with kinked tubing and others with buttons difficult to push.".

Manufacturer Narrative

H6.Investigation summary: bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by visual examination and functional testing, each having their safety buttons activated, and no issues were observed relating to damaged tubing or difficult to activate as all samples met specifications.A review of the device history record indicated a quality notification was raised for this issue.However, lot passed all in-process and final quality checks for lot release.This complaint is unable to be confirmed for the indicated failure modes damaged tubing and difficult to activate.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set that it was kinked and tubing with buttons that are difficult to push.The following information was provided by the initial reporter.The customer stated: "according to the customer's report, there were products with kinked tubing and others with buttons difficult to push.".

• Brand Name: BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17221170
• MDR Text Key: 318569604
• Report Number: 9617032-2023-00809
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673648
• UDI-Public: 50382903673648
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/29/2023

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 Model Number: 367364
• Device Catalogue Number: 367364
• Device Lot Number: 2230228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2022
• 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