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

Lot Number 200408

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual testing was performed.Visual inspection found the tip of the glass syringe was damaged.The following are possible causes of this event: a damaged syringe was overlooked in the 100% inspection in the manufacturing process.The syringe was damaged by impact during sterilization after packing or during transportation.This event may have been overlooked during the inspection, however it was not possible to identify when and what caused the syringe breakage.In order to prevent recurrence, we made the occurrence of this event known to all workers in the related processes, and re-educated the inspection points such as cracks in the syringe tip in the procedure manual for visual inspection of the syringe.In addition, we will continue to monitor the occurrence of similar events and take appropriate measures.Model #, operator of device, and report source 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 cms# (b)(4).

Event Description

It was reported that after opening the package, the customer attempted to draw medical fluid using the syringe at a pre-use check, but could not do it.After that, he noticed the syringe was broken.No patient injury was reported.

• Brand Name: PORTEX CONTINUOUS EPIDURAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15316871
• MDR Text Key: 305424376
• Report Number: 3012307300-2022-16645
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K781052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2022

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 Lot Number: 200408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2022
• 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