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

Catalog Number 405122

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 08/16/2023

Event Type  malfunction  

Event Description

It was reported that the bd quincke spinal needle experienced incorrect color on device.The following information was provided by the initial reporter: colour of the hub of the needle is change in different batch of both 23g and 25g.Customer's query is why there is colour change in different batch of same product.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: two photos were provided to our quality team for investigation.The photos provided display lot 2110029 which has a deeper orange hub color and lot 2302020 which is a lighter orange color.Based on our visual inspection, the hub is observed to be the correct color for each lot.A device history review was performed for lot 2110029, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.A change of the needle hub color was implemented and approved in september 2022 for 25g needles to comply with iso 6009, changing the color from a more vibrant orange to be lighter as seen in the photos provided.Based on the sample evaluation and our quality team's investigation, no defect was observed on the product as the change in hub color was approved and implemented after the manufacturing of lot 2110029.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

Event Description

It was reported that the bd quincke spinal needle experienced incorrect color on device.The following information was provided by the initial reporter: colour of the hub of the needle is change in different batch of both 23g and 25g.Customer's query is why there is colour change in different batch of same product.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17662789
• MDR Text Key: 322415950
• Report Number: 3003152976-2023-00364
• 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: 10/12/2023

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: 405122
• Device Lot Number: 2110029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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