MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367324

Device Problems Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)

Patient Problems Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2022

Event Type  Injury  

Event Description

It was reported when using the bd vacutainer® push button blood collection set, the user experienced a needlestick injury, post use while trying to activate the safety feature.This event occurred once.Medical intervention, post procedural protocol occurred.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that the safety shield did not retract properly thus resulting in a needle stick injury.Did exposure to blood occur? yes, the needle that caused the needlestick had already been used on a patient.If it did, was there any post exposure testing or medical intervention? yes, we followed our ¿needlestick¿ protocol for patient and source testing.Customer concern: one of our staff members had a needle stick today because she pushed the button on the butterfly needle for retraction, heard a snap, but didn't realize the needle didn't disappear and stuck her finger.This happened today (b)(6) 2022) at 8:20 am.She was using a vacutainer holder and drew 2 tubes.No redraw was necessary.

Manufacturer Narrative

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

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2022-10-20.H.6.Investigation summary: bd received 10 samples for investigation.The samples were evaluated by visual examination and functional testing and the indicated failure mode for retraction failure with the incident lot was not observed as all product specifications were met.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.H3 other text : see h.10.

Event Description

It was reported when using the bd vacutainer® push button blood collection set, the user experienced a needlestick injury, - post use while trying to activate the safety feature.This event occurred once.Medical intervention, -post procedural protocol occurred.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that the safety shield did not retract properly thus resulting in a needle stick injury.Did exposure to blood occur? yes, the needle that caused the needlestick had already been used on a patient.If it did, was there any post exposure testing or medical intervention? yes, we followed our ¿needlestick¿ protocol for patient and source testing.Customer concern: one of our staff members had a needle stick today because she pushed the button on the butterfly needle for retraction, heard a snap, but didn't realize the needle didn't disappear and stuck her finger.This happened today ((b)(6) 2022) at 8:20 am.She was using a vacutainer holder and drew 2 tubes.No redraw was necessary.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15639368
• MDR Text Key: 302084642
• Report Number: 1710034-2022-00609
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903673247
• UDI-Public: 00382903673247
• 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,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 367324
• Device Lot Number: 2074439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2022
• 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
• Patient Outcome(s): Required Intervention