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 08/08/2023

Event Type  malfunction  

Manufacturer Narrative

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 is kinked.This event occurred 4 times.The following information was provided by the initial reporter.The customer stated: "preactivation and tube kink.".

Event Description

It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set is kinked.This event occurred 4 times.The following information was provided by the initial reporter.The customer stated: "preactivation and tube kink.".

Manufacturer Narrative

The following fields have been updated with additional information: d.10 device available for eval? yes.D.10 returned to manufacturer on: 29-aug-2023.H.6.Investigation summary: bd received 4 samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for crimped tubing with the incident lot was observed.Additionally, 30 retention samples from bd inventory were evaluated by visual examination and the issue crimped tubing was 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 mode crimped tubing.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17601061
• MDR Text Key: 321716616
• Report Number: 9617032-2023-01138
• 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: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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