MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SPINAL NEEDLE 27GA 3.50 IN; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 405259

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that drug leaked from the side of the spinal needle 27 ga 3.50 in during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "the drug is dispensed 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 may be required, the calculation of the administered dose is also lost, increases the risk of failed spinal anesthesia, there is a risk of over or underdosing.".

Manufacturer Narrative

Investigation summary: no photos or physical samples that display the reported condition were available for investigation.Three retained samples of the lot 1910022 were used for additional evaluation.The product was visual inspected, no damage or defects were observed on any of the product.Drip testing was performed, the samples were connected to the appropriate luer fitting, all connections were secure, and no leakage from the hub occurred.The needle was then connected to a syringe and additional leakage testing was conducted, in all cases the product functioned as intended and no leakage was identified.Product undergoes visual and functional testing throughout manufacturing to ensure the quality of the device, including verification that all critical dimensions are within specification.A device history review was performed for lot 1910022, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on the available information we are not able to identify a root cause at this time.

Event Description

It was reported that drug leaked from the side of the spinal needle 27ga 3.50 in during use.The following information was provided by the initial reporter, translated from spanish to english: "the drug is dispensed 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 may be required, the calculation of the administered dose is also lost, 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
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 10617011
• MDR Text Key: 211130851
• Report Number: 3002682307-2020-00294
• 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: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405259
• Device Lot Number: 1910022
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other