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

Catalog Number 405084

Device Problem Break (1069)

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

Event Date 11/17/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 by the customer that 3 of the bd quincke¿ spinal needle broke.The following information was provided by the initial reporter, translated from italian to english: update on 25th nov 2022.As agreed, i am sending the photograph of the needle broken at the base and the angled mandrel.The product was not used on the patient.When the device is opened, the needle and the stylet at the base of the handle break.During the sliding movement of the stylet in the needle, considerable friction is observed, resulting in non-reversible angulation of the stylet.This nobilisation test (a routine maneuver that is performed before use on the patient) was performed on at least 3 pieces found to have the same problem.

Event Description

It was reported by the customer that 3 of the bd quincke¿ spinal needle broke.The following information was provided by the initial reporter, translated from italian to english: update on 25th nov 2022 as agreed, i am sending the photograph of the needle broken at the base and the angled mandrel.The product was not used on the patient.--------------------- when the device is opened, the needle and the stylet at the base of the handle break.During the sliding movement of the stylet in the needle, considerable friction is observed, resulting in non-reversible angulation of the stylet.This nobilisation test (a routine maneuver that is performed before use on the patient) was performed on at least 3 pieces found to have the same problem.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 13-dec-2022.H6: investigation summary one photo, the impacted sample, and ten unused samples were provided to our quality team for investigation.Upon inspection of the photo, the stylet is shown to be bent.The physical sample and unused samples were evaluated using magnification, no damage or defects were observed.Functional testing was performed and no friction identified, the components could be separated without issue.A device history review was performed for lot 2010010, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Product undergoes a series of testing and inspections throughout the manufacturing process the ensure the quality and functionality of the device, including verification the needle is free from damage or defects and all critical dimensions are within specification.All inspections for lot 2010010 were completed according to procedure, no annotations were noted related to the reported incident.Based on the available information we are not able to identify a root cause related to our manufacturing process at this time.H3 other text : see h10.

• Brand Name: BD QUINCKE¿ 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: 15946988
• MDR Text Key: 308078184
• Report Number: 3003152976-2022-00546
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K210078
• 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: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405084
• Device Lot Number: 2010010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 01/31/2023
• Supplement Dates FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2020
• 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