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

Catalog Number 405121

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/01/2021

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 bd quincke spinal needle contained foreign material.The following information was provided by the initial reporter: ".In (b)(6) hospital spinal needle 22g uit were found with rust.".

Event Description

It was reported bd quincke spinal needle contained foreign material.The following information was provided by the initial reporter: ".In tagore heart care hospital spinal needle 22g uit were found with rust.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 14-jan-2022.H.6.Investigation: three samples were provided to our quality team for investigation.Through visual inspection, brown stains were observed confirming rust or corrosion stains on the packaging and needle guard.It can be seen with the naked eye that all three packages are broken, two on the paper side (cracked) and one on the film side.If the packaging is open or broken it is possible these needles have been wet in some part of the transport process or in storage.The stainless steel of the needles could be oxidized by chlorine.Further analysis was conducted, there is no evidence of any problem with the shipping and storage of these needles to determine the root cause of this corrosion.A review of the device history for lot 2003020 was performed and no deviations or nonconformities were identified during the manufacturing process that could have contributed to this problem.The product is visually and functionally inspected throughout the manufacturing process in accordance with the procedure, verifying that all critical dimensions are within specification and that there is no product damage or defects.All records have been reviewed and no problems were identified during the inspections of the reported lots.Based on the information available, we are unable to identify a definitive root cause at this time.

• 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: 13115133
• MDR Text Key: 285621523
• Report Number: 3003152976-2021-00870
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 05/09/2022

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: 405121
• Device Lot Number: 2003020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 05/09/2022
• Supplement Dates FDA Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2020
• 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