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

Catalog Number 367336

Device Problem Difficult or Delayed Activation (2577)

Patient Problem Discomfort (2330)

Event Date 07/31/2023

Event Type  malfunction  

Event Description

It was reported that during use with bd vacutainer® push button blood collection set it was difficult to activate the safety feature.This is 1 of 2 reports.The following information was provided by the initial reporter, translated from french to english: during blood sampling, the nurse encounters difficulties with the safety of the device when retracting the needle.They were resistant on 2 samplings.Patient or user impact: patient's vein injured, resulting in an effusion.

Manufacturer Narrative

There were multiple medical device types reported to be involved.The information for the additional device type is as follows: d.1 medical device type: fpa.D.2.Common device name: intravascular administration set.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by functional testing, each of their safety features being activated, and no issues were observed relating to unable to retract 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 unable to retract.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 that during use with bd vacutainer® push button blood collection set it was difficult to activate the safety feature.This is 1 of 2 reports.The following information was provided by the initial reporter, translated from french to english: during blood sampling, the nurse encounters difficulties with the safety of the device when retracting the needle.They were resistant on 2 samplings.Patient or user impact: patient's vein injured, resulting in an effusion.

• Brand Name: BD VACUTAINER® 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: 17561164
• MDR Text Key: 321810880
• Report Number: 9617032-2023-01109
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673365
• UDI-Public: 50382903673365
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K220212
• 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: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367336
• Device Lot Number: 2248340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2022
• 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