MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SPINAL SET 26GA 3-1/2IN; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 405065

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

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 the spinal set 26ga 3-1/2in was blocked during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "very soft needle, poor flow through the needle, poor visibility of the cerebrospinal fluid".

Manufacturer Narrative

H6: investigation summary no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for reported lot 1607013, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples of lot 1607013 were used for additional evaluation.The product was visually inspected, no damage or defects was observed on any of the product.Functional evaluations were performed, no friction was noted during the connection of the samples and the needle could smoothly advance through the introducer.Dimensional testing was performed on the retained samples, verifying all critical dimensions are within specification including the internal diameter of both the cannula and the introducer.Product undergoes visual inspections throughout the manufacturing process, verifying no defects on the product.Inspection results were reviewed for the reported lot and no issues were identified.Based on our investigation, we are not able to identify a root cause at this time.See h.10.

Event Description

It was reported that the spinal set 26ga 3-1/2in was blocked during use.The following information was provided by the initial reporter, translated from polish to english: "very soft needle, poor flow through the needle, poor visibility of the cerebrospinal fluid".

• Brand Name: SPINAL SET 26GA 3-1/2IN
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• MDR Report Key: 10743460
• MDR Text Key: 214798966
• Report Number: 3002682307-2020-00327
• 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: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 405065
• Device Lot Number: 1607013
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1