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

Model Number 367324

Device Problem Difficult or Delayed Activation (2577)

Patient Problem Exposure to Body Fluids (1745)

Event Date 07/14/2021

Event Type  Injury  

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.

Event Description

It was reported when using the bd vacutainer® push button blood collection set, the device experienced retraction issue causing a needle stick post use.The following information was provided by the initial reporter.The customer stated: yesterday unc rn had a needle stick after drawing a patient¿s blood.She attempted to retract the needle as expected several times and the needle would not retract.

Event Description

It was reported when using the bd vacutainer® push button blood collection set, the device experienced retraction issue causing a needle stick post use.The following information was provided by the initial reporter.The customer stated: yesterday unc rn had a needle stick after drawing a patient¿s blood.She attempted to retract the needle as expected several times and the needle would not retract.

Manufacturer Narrative

H.6.Investigation: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for retraction with the incident lot was not observed.The customer photo does not show the actual device, or any defects associated with the device as only the top web is visible.Investigation into needle retraction failure cannot be conducted using the photo provided.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.Bd was not able to identify a root cause for the indicated failure mode.One box of fifty retains was pulled for retraction testing.Upon visual inspection of the retains no damage or defects were observed.The retraction button was pressed, and all fifty units retracted immediately and fully into the barrel of the devices.H3 other text : see h.10.

• 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
• MDR Report Key: 12277603
• MDR Text Key: 265205477
• Report Number: 1710034-2021-00661
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673242
• UDI-Public: 50382903673242
• Combination Product (y/n): N
• PMA/PMN Number: K030573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 367324
• Device Catalogue Number: 367324
• Device Lot Number: 1035534
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other