MAUDE Adverse Event Report: NULL PORTEX EPIFUSE EPIDURAL CATHETER CONNECTOR; ANESTHESIA CONDUCTION KIT

Model Number	4909E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suspect device was damaged after the user opened the unit.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.The suspect device was returned for investigation and visual and functional testing was performed.As a result of observing the sample, it was confirmed that the hinge part of the suspect device connectors was broken and split in two parts.At the manufacturing process of the kit, the suspect device was thoroughly inspected and the appearance of the suspect device connector for any deformation or damage before incorporating it into the kit.Therefore, the following possibilities are confirmed, but the cause and timing of occurrence were not specified.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX EPIFUSE EPIDURAL CATHETER CONNECTOR
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15327804
• Report Number: 3012307300-2022-17024
• Device Sequence Number: 12097079
• Product Code: CAZ
• UDI-Device Identifier: 10351688076083
• UDI-Public: 10351688076083
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4909E
• Device Catalogue Number: 4909E
• Device Lot Number: 200706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown