MAUDE Adverse Event Report: NULL PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number 4935MG-17

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

It was reported that the epidural and kits are coming unclipped or the catheter is disconnecting from the clip while they are still closed.No patient injury was reported.

Manufacturer Narrative

This mdr was generated under protocol b10009704 as a result of warning letter cms#: 617147.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.The device was received for evaluation.Visual and functional testing were performed.Visual inspection revealed that the original packaging of one of the trays had been opened prior to receipt.The catheter and connector of this tray was already assembled, but did not appear to have been used on a patient.However, this sample was not included within the following investigation.All remaining trays were unopened original packages.Visual inspection of the remaining samples (all lots) did not reveal any defects or anomalies with the catheters or the connectors.During functional testing, the catheter and connector samples were tested as an assembly (catheter to a detachable hub).Two of twenty-two samples from one lot and one sample from another lot, failed to remain assembled when tested.The inside diameter of the connectors from the failed assemblies were inspected for defects following the test.No defects or anomalies were found.The separation of the components confirmed the complaint.However, the root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.Udi is unknown.No product information has been provided to date.

• Brand Name: PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15634374
• MDR Text Key: 307007498
• Report Number: 3012307300-2022-25181
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K781052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Catalogue Number: 4935MG-17
• Device Lot Number: 3746304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• 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