MAUDE Adverse Event Report: PERISAFE I 17 X 3-1/2IN; ANESTHESIA CONDUCTION KIT

Catalog Number 405067

Device Problems Failure to Deliver (2338); Material Deformation (2976)

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

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.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 perisafe i 17 x 3-1/2in had a blockage issue.The following information was provided by the initial reporter, translated from (b)(6): "at the time of performing the anesthesia procedure under epidural block, by the anesthesiologist, the procedure was presented or is obstructed due to equipment failure, there was a defect in the tip of the perisafe equipment bevel.".

Manufacturer Narrative

H.6.Investigation: since no photos or samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.H3 other text : see h.10.

Event Description

It was reported perisafe i 17 x 3-1/2in had a blockage issue.The following information was provided by the initial reporter, translated from spanish: "at the time of performing the anesthesia procedure under epidural block, by the anesthesiologist, the procedure was presented or is obstructed due to equipment failure, there was a defect in the tip of the perisafe equipment bevel.".

• Brand Name: PERISAFE I 17 X 3-1/2IN
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 12554304
• MDR Text Key: 274288406
• Report Number: 9610847-2021-00475
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2024
• Device Catalogue Number: 405067
• Device Lot Number: 9127781
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2019
• 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: 39 YR
• Patient Weight: 75