MAUDE Adverse Event Report: SPINAL SET 26GA 3-1/2IN; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 405065

Device Problem Complete Blockage (1094)

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

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter first name: (b)(6).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 1712004, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples of lot 1712004 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.

Event Description

It was reported that 3 spinal set 26ga 3-1/2in were clogged during use.The following was reported by the initial reporter: "chief physician dr.Reyle-hahn reports that the return flow in the cannula mentioned is insufficient.The problem has been occurring for about 8 weeks.Not all cannulas are equally affected.Can we clarify the failure.Is there a flow issue/block in the needle? is this related to a flashback for needle positioning? -1st follow up sent on 16/04/2021 answer: the reflux in the aforementioned cannula is deficient.The problem has been occurring for about 8 weeks.Not all cannulas are affected equally.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 5/3/2021.H.6.Investigation: three samples were provided to our quality team for investigation.The product was inspected using magnification, no defects or blockages were observed and the cannula and stylet could advance through the introducer without any friction.A device history review was performed for reported lot 1712004, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples of lot 1712004 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 returned and 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 and sample evaluation, we are not able to identify a root cause at this time.H3 other text : see h.10.

Event Description

It was reported that 3 spinal set 26ga 3-1/2in were clogged during use.The following was reported by the initial reporter: "chief physician dr.Reyle-hahn reports that the return flow in the cannula mentioned is insufficient.The problem has been occurring for about 8 weeks.Not all cannulas are equally affected.Can we clarify the failure.Is there a flow issue/block in the needle? is this related to a flashback for needle positioning? 1st follow up sent on (b)(6) 2021.Answer: the reflux in the aforementioned cannula is deficient.The problem has been occurring for about 8 weeks.Not all cannulas are affected equally.".

• Brand Name: SPINAL SET 26GA 3-1/2IN
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• MDR Report Key: 11822733
• MDR Text Key: 253493428
• Report Number: 3003152976-2021-00261
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 405065
• Device Lot Number: 1712004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Date Manufacturer Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2018
• 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