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

Catalog Number 367342

Device Problem Fail-Safe Did Not Operate (4046)

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

Event Date 09/26/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this.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® push button blood collection set, the user identified a needle retraction issue.This issue occurred once.The following information was provided by the initial reporter.The customer stated: customer states that the push button needle 367342 lot no.2167601 did not retract.Hazard, injury or erroneous results? no.

Event Description

It was reported when using the bd vacutainer® push button blood collection set, the user identified a needle retraction issue.This issue occurred once.The following information was provided by the initial reporter.The customer stated: customer states that the push button needle 367342 lot no.2167601 did not retract.Hazard, injury or erroneous results? no.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos for investigation.Therefore, 30 retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to retraction failure as all samples met specifications.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 for the indicated failure mode retraction failure.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.

• Brand Name: BD VACUTAINER® 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: 15553640
• MDR Text Key: 305800402
• Report Number: 1024879-2022-00590
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903673421
• UDI-Public: 00382903673421
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030573
• 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,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367342
• Device Lot Number: 2167601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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