MAUDE Adverse Event Report: NULL CATHETER; ANESTHESIA CONDUCTION KIT

Device Problem Break (1069)

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

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.As a result of observing each sample, it was confirmed that the hinge part of the connector of sample one (1) was damaged.Sample two (2) did not show any abnormal appearance, we locked and unlocked 10 times, but no abnormality was found.The reported event was confirmed.Therefore, the following are possible, but the cause and timing of the occurrence could not be identified.The suppliers and manufacturing departments will be notified of the occurrence of this event, monitor the trend of similar events, and take appropriate measures depending on the situation.Devies are unknown.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).

Event Description

It was reported that after inserting the catheter into the connector, when locking it, the customer found a break in its hinge part.No patient injury was reported.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CATHETER
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15316021
• MDR Text Key: 305249618
• Report Number: 3012307300-2022-16602
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1