MAUDE Adverse Event Report: NULL PAIN MANAGEMENT PORTEX KITS OTHER; ANESTHESIA CONDUCTION KIT

Device Problem Defective Component (2292)

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

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

No information has been provided to date.Therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.It was confirmed that part of the hook did not get caught and could not be locked.This cover is visually inspected for the normal function of the hooks during the kit manufacturing process.Possible root causes of this event are deformation was not detected in the inspection.And product deformed because it was sterilized with a load on the hook.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.

Event Description

It was reported that the cover of product was unable to be closed.No patient injury was reported.

• Brand Name: PAIN MANAGEMENT PORTEX KITS OTHER
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15401836
• MDR Text Key: 305879933
• Report Number: 3012307300-2022-18660
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1