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

Catalog Number 367364

Device Problems Nonstandard Device (1420); Shielding Failure (1568)

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

Event Date 05/06/2022

Event Type  malfunction  

Manufacturer Narrative

There were multiple device types reported to be involved.The information for the additional device types are as follows.Medical device type: jka / fpa.Common device name: blood specimen collection device; intravascular administration set.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, the user identified the product tubing had a kink.This event occurred 4 times.The following information was provided by the initial reporter.The customer stated: this is a report about bent tubing and preactivation of wingset utpbbcs according to the customer's report, the tubing was found to be bent with preactivation in several products before use.

Manufacturer Narrative

The following fields have been updated with additional info: d.9.Device available for eval? yes.D.9 returned to manufacturer on: 19-aug-2022.H.6.Investigation summary: bd received 3 physical samples as well as 3 photos from the customer in support of this complaint.The photos and samples were evaluated and revealed bd pbbcs devices appearing to have a preactivation of the iv needle and iv protector as well as a kinked tubing.Bd is able to confirm the customer¿s reported failure from the photos and sample received.The root cause of the kinked tubing would be preactivation of the iv needle in the package as this would cause the tubing to push down against the bottom of the blister pack.A definite root cause of the preactivation could not be determined.Based on a review of batch records, no root cause from manufacturing was identified as a contributor.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.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, the user identified the product tubing had a kink.This event occurred 4 times.The following information was provided by the initial reporter.The customer stated: this is a report about bent tubing and preactivation of wingset utpbbcs according to the customer's report, the tubing was found to be bent with preactivation in several products before use.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14403012
• MDR Text Key: 291970558
• Report Number: 1024879-2022-00268
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903673643
• UDI-Public: 00382903673643
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153309
• 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: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 367364
• Device Lot Number: 1228667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2021
• 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