MAUDE Adverse Event Report: SPINAL NEEDLE 27GA 3.50 IN; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 405259

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date.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 that medicine leaked from the sides of the spinal needle 27ga 3.50 in during use when the luer-lock did not close completely.The following information was provided by the initial reporter, translated from (b)(6) to english: "the drug is spilled from the sides because the luer lock does not close properly, which is why the dose is lost, requires positioning of the needle, the puncture may be lost and a new one is required, the calculation of the administered dose increases the risk of failed spinal anesthesia, there is a risk of over or underdosing.".

Manufacturer Narrative

H.6.Investigation: no samples or photos received for investigation.Retained samples were evaluated, no anomalies were observed.Functional test was performed, sample was connected to a syringe, during the test the fluid passed from the syringe through the spinal needle and no leakage was noted at the luer connection.A device history review was performed for lot 1807712, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Since no annotation or no conformances were found during dhr review that could be related with the event reported, lot release testing do not indicate any issue and retained samples received pass functionality testing , the incidence reported cannot be confirmed, and therefore; root cause cannot be established at this time.H3 other text : see h.10.

Event Description

It was reported that medicine leaked from the sides of the spinal needle 27ga 3.50 in during use when the luer-lock did not close completely.The following information was provided by the initial reporter, translated from spanish to english: "the drug is spilled from the sides because the luer lock does not close properly, which is why the dose is lost, requires positioning of the needle, the puncture may be lost and a new one is required, the calculation of the administered dose increases the risk of failed spinal anesthesia, there is a risk of over or underdosing.".

• Brand Name: SPINAL NEEDLE 27GA 3.50 IN
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• MDR Report Key: 12436742
• MDR Text Key: 270326853
• Report Number: 3002682307-2021-00463
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

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: 405259
• Device Lot Number: 2011009
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• 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
• Patient Age: 54 YR