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

Catalog Number 367364

Device Problem Material Twisted/Bent (2981)

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

Event Date 10/24/2023

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.E.1.Initial reporter facility name: (b)(6) center, fukuoka public health promotion organization.

Event Description

It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set needles are not coming out of the hub.This event occurred 6 times.The following information was provided by the initial reporter.The customer stated: this is a complaint about bent tubes, needles not coming out from the hub.

Manufacturer Narrative

Bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure modes for preactivation and bent tubing were observed.Additionally, 30 retention samples from bd inventory were evaluated by visual examination and upon completion the indicated failure modes for preactivation and bent tubing were not observed.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 modes preactivation and bent tubing.Bd has initiated further root cause investigation relating to the issues of preactivation and bent tubing through corrective and preventive actions.

Event Description

It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set needles are not coming out of the hub.This event occurred 6 times.The following information was provided by the initial reporter.The customer stated: this is a complaint about bent tubes, needles not coming out from the hub.

• Brand Name: BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• 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: jo doyka ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 18078621
• MDR Text Key: 328488322
• Report Number: 9617032-2023-01592
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673648
• UDI-Public: (01)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: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367364
• Device Lot Number: 2230228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• 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