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

Catalog Number 405076

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/01/2023

Event Type  Injury  

Event Description

It was reported while using bd® whitacre spinal needles set the course of treatment was altered as a result of the device's function.The following information was provided by the initial reporter: the needles are substandard when compared to the orange 25g spinal needles previously supplied.Problems with new spinal needles: 1.Introducer requires significantly more force to insert.2.Directional indicator on spinal needle difficult to see.3.Extremely difficult to feel distinct "popping" sensation when entering subarachnoid space.4.Extremely slow backflow of csf.Additionally it was stated: please see the feed back regarding the new bd spinal needles.Other anaesthetic team members are also unhappy and are raising concerns.Other complain is that they are flimsy and bend very easily.This has a potential of needle breaking in a patient back.The introducer and needle length also seem smaller.15/jun/23: info received: 1.Can they verify, did a needle actually break inside a patient or are they alleging they are flimsy and bend easily? = luckily no needle has broken inside a patient, but they are flimsy and bend very easily.The quality is not good, compared to the needles used previously.2.Can you provide the reference needle they were previously using, was it the quincke 25g spinal needle ? =kdh is using whitacre pencil point 25 g needles not quincke 25g spinal needles.3.Has there been any patient impact as a result of these issues? if yes, please provide specific details.= indeed there been patient impact in terms of : failed spinals and unnecessary conversion to general anesthesia especially in obstetric patients.This group is considered high risk for potentially difficult airway and an aspiration risk, when comes to ga.Increased numbers of patchy spinal, because no dural pop is felt ,as the needle advances through the structures.

Manufacturer Narrative

H.3.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 needles set the course of treatment was altered as a result of the device's function.The following information was provided by the initial reporter: the needles are substandard when compared to the orange 25g spinal needles previously supplied.Problems with new spinal needles: 1.Introducer requires significantly more force to insert.2.Directional indicator on spinal needle difficult to see.3.Extremely difficult to feel distinct "popping" sensation when entering subarachnoid space.4.Extremely slow backflow of csf.Additionally it was stated: please see the feed back regarding the new bd spinal needles.Other anaesthetic team members are also unhappy and are raising concerns.Other complain is that they are flimsy and bend very easily.This has a potential of needle breaking in a patient back.The introducer and needle length also seem smaller.15/jun/2023: info received: 1.Can they verify, did a needle actually break inside a patient or are they alleging they are flimsy and bend easily? = luckily no needle has broken inside a patient, but they are flimsy and bend very easily.The quality is not good, compared to the needles used previously.2.Can you provide the reference needle they were previously using, was it the quincke 25g spinal needle ? =kdh is using whitacre pencil point 25 g needles not quincke 25g spinal needles.3.Has there been any patient impact as a result of these issues? if yes, please provide specific details.Indeed there been patient impact in terms of : failed spinals and unnecessary conversion to general anesthesia especially in obstetric patients.This group is considered high risk for potentially difficult airway and an aspiration risk, when comes to ga.Increased numbers of patchy spinal, because no dural pop is felt ,as the needle advances through the structures.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 21-jul-2023.H6: investigation summary: twenty-five unused samples were provided to our quality team for evaluation.The products were visually inspected using magnification, no damage or other defects were identified, the directional indicator is clearly visible and well positioned.A device history review was performed for lot 2301021, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three retained samples of the same lot were used for additional evaluation, no defects were observed on the needle, the external diameter of the cannulas were measured and verified all product was within required limits.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 2301021 were completed according to procedure, no annotations were noted related to the reported incident.The returned products along with the three retained samples were also evaluated and verified all product met required specifications, no issues were observed that could have contributed to any of the reported concerns.Based on the information provided initially, it is evident that several of the dissatisfactions noted are in relation to the difference between the design of the two different needles quincke 25 spinal needle (orange) which the customer was previously using and the whitacre 25 spinal needle (blue) which they are currently using.The cannula of the whitacre needle is pencil type and the opening for the passage of the liquid is smaller than the cannula of the quincke, which may cause the fluid to flow more slowly than what one would be used to with the quincke.Given we could not identify any defects on the products evaluated, no device failure or root cause can be identified at this time.It appears the concerns reported relate to the difference in products previously used compared to what is currently in use at the facility at this time.

• Brand Name: BD® WHITACRE SPINAL NEEDLES SET
• 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: 17283176
• MDR Text Key: 318647528
• Report Number: 3003152976-2023-00277
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 405076
• Device Lot Number: 2301021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 08/09/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2023
• 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
• Patient Outcome(s): Required Intervention