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

Catalog Number 405129

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd whitacre¿ spinal needle the label was not what was inside the box.This affected 25 pieces.There was no report of patient impact.The following information was provided by the initial reporter: found that bd quincke needle 23g was in the box instead of whitacre 25g.

Manufacturer Narrative

H6: investigation summary: two photos received by our quality team for investigation.Upon visual evaluation, the case is identified on the label with lot number 2109012 and with reference 405129 which corresponds to whitacre set with 25ga x 3.50in caliber introducer.Inside the box there are spinal needles with lot number 2207003 with reference 405120 which corresponds to spinal needle of caliber 23ga x 3.50in.A device history review was performed for reported lot 2109012, 2207003 no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based upon the quality team's investigation, we were unable to determine the root cause for the alleged defect at this time.

Event Description

It was reported while using bd whitacre¿ spinal needle the label was not what was inside the box.This affected 25 pieces.There was no report of patient impact.The following information was provided by the initial reporter: found that bd quincke needle 23g was in the box instead of whitacre 25g.

• Brand Name: BD 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 ; 8448235433
• MDR Report Key: 16587490
• MDR Text Key: 312284963
• Report Number: 3003152976-2023-00082
• 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: 05/04/2023

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: 405129
• Device Lot Number: 2204022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 05/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• 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