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 12/18/2021

Event Type  malfunction  

Event Description

It was reported that incorrect spinal needles were mixed into the boxes of 50 bd whitacre¿ spinal needles.The following information was provided by the initial reporter: "distributor received 2 boxes (25 units) of whitacre 25g spinal needle.However they received different items in each box except whitacre 25g sponal needle.Among these, 1 box contains 25 units of quincke spinal needle 27g and another box contains whitacre spinal needle 27g".

Manufacturer Narrative

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: photos received for investigation.Upon visual inspection, the photos show that the case is identified on the label with 25ga 3.5 in whitacre set with batch 1901013.Date of manufacture 16-jan.-19.And with reference 27ga 3.50in quincke lot1904005 date of manufacture 13-mar.-19.And 27ga 3.50in whitacre set lot 1903006 date of manufacture on 4-abr.-19.A device history review was performed for reported lot 1901013,1904005,1903006, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.The mix could not be produced in our manufacturing plant as these three batches did not cohere in the manufacturing plant.The cases are very manipulated and broken, the opening flap of the case which may give indications of manipulation after the manufacture, the boxes look very damaged which gives us an indication that they have been handled.Therefore, it can be concluded that there could not have been any mixing of products during sterilization, since there is a 2 month difference between the three batches.Possible root cause is associated with the distribution center.The lot was repackaged because the invoice was for a lower quantity than requested.In some of the distribution centers the cases are handled and repacked in other boxes to be sent to the customer, and it could happen that less needles are sent due to human error.

Event Description

It was reported that incorrect spinal needles were mixed into the boxes of 50 bd whitacre¿ spinal needles.The following information was provided by the initial reporter: "distributor received 2 boxes (25 units) of whitacre 25g spinal needle.However they received different items in each box except whitacre 25g "spinal" needle.Among these, 1 box contains 25 units of quincke spinal needle 27g and another box contains whitacre spinal needle 27g.".

• 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 ; 8015296192
• MDR Report Key: 13239998
• MDR Text Key: 284529545
• Report Number: 3003152976-2021-00899
• 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,Distributor
• 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

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 405129
• Device Lot Number: 1901013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2019
• 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