MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD UNIVIA¿ WHITACRE SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 405075

Device Problem Defective Device (2588)

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

Event Date 12/22/2021

Event Type  malfunction  

Manufacturer Narrative

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 that the bd univia¿ whitacre spinal needle would not thread through the introducer needle and got stuck in it.The following information was provided by the initial reporter: "in several samples the needle does not slide through the introducer but it sticks in it, and as a result there is friction between the metals of the needle and the introducer.She claims that there is also a sound of friction between the metals of the needle and the introducer and that except the inability to enter the subarachnoid space, there might be metal shavings that could cause meningitis.".

Event Description

It was reported that the bd univia¿ whitacre spinal needle would not thread through the introducer needle and got stuck in it.The following information was provided by the initial reporter: "in several samples the needle does not slide through the introducer but it sticks in it, and as a result there is friction between the metals of the needle and the introducer.She claims that there is also a sound of friction between the metals of the needle and the introducer and that except the inability to enter the subarachnoid space, there might be metal shavings that could cause meningitis.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 2022-01-10.H6: investigation summary: two samples received for investigation.Upon visual inspection at 10x magnification, no defect of incorrect assembly was observed.The hub of the needle and the flaring of the cannula where it engages with the molded hub is correct.No crushing can be seen at this point, which is where gripping can occur.The needle is removed from the introducer and reassembled to detect the grip or friction mentioned by the customer.The samples were inspected (magnifying glass and microscope used) and no defects were found.A device history review was performed for the reported lot 2009019 no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Retained samples of the same lot were used for additional evaluation.The product was visually inspected and no defects were identified.The stylets were inserted through the introducers, no friction was noted during connection and the needle could smoothly advance without issue in all samples evaluated.The internal diameter of the introducers was measures and found to be within specification.Product undergoes a series of testing and inspections throughout the manufacturing process to ensure the quality and functionality of the device.All lot release testing was reviewed and found product met requirements, no issues were identified.Based on the quality team's investigation, a root cause related to our manufacturing process cannot be identified at this time.

• Brand Name: BD UNIVIA¿ WHITACRE SPINAL NEEDLE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13294931
• MDR Text Key: 285483588
• Report Number: 3003152976-2022-00005
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: NA
• 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: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 405075
• Device Lot Number: 2009019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2020
• 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