MAUDE Adverse Event Report: NULL PORTEX KITS OTHER; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number EPX616/118DJP

Device Problem Device Damaged by Another Device (2915)

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

Event Date 03/01/2020

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.The connector part was received but not the catheter; therefore, visual and functional testing could not be performed on the catheter.Testing was performed using our stock catheter into the actual connector.The reported issue could not be confirmed as only one component was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.D4 and g2 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# 617147.

Event Description

It was reported that when the customer was inserting the catheter into the connector, the catheter pierced the other side of the connector.Customer stopped using the product.No patient injury was reported.

• Brand Name: PORTEX KITS OTHER
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section G): NULL
• MDR Report Key: 15326763
• MDR Text Key: 302946296
• Report Number: 3012307300-2022-16938
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: EPX616/118DJP
• Device Lot Number: 191015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 08/31/2022
• 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