MAUDE Adverse Event Report: BECTON DICKINSON BD CATHETER ROUND CE; CATHETER INDUCER

Catalog Number 401497

Device Problems Material Rupture (1546); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).In this mdr, bd corporate headquarters in (b)(6) has been listed.Teleflex is an oem manufacturing site.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd catheter round ce ruptured during removal and adjustment in the epidural space."the piece of the catheter has not been found, but there is no negative consequence for the patient at this time." medical intervention included chest ct scan and mri of thoracic and whole spine." no further information given at this time.

Manufacturer Narrative

Investigation results: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Finished device: device history records for finished product part number evaluated.Line clearance, first article, in-process inspection and final qa inspection performed without any quality issues.Product is documented as having met all form, fit and functional requirements at time of shipment.Subcomponent: device history records for subcomponent product part number evaluated.Line clearance, first article, in-process inspection and final qa inspection performed without any quality issues.In-process dimensional and performance records for the subcomponent lots evaluated against requirements.No issues identified.No information from the review of the processes, raw or finished materials , or equipment indicates that the finished product was non - conforming at time of shipment.No root cause can be determined as no samples were received for investigation.No capa is required.

• Brand Name: BD CATHETER ROUND CE
• Type of Device: CATHETER INDUCER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7266372
• MDR Text Key: 100142393
• Report Number: 2243072-2018-00023
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 401497
• Device Lot Number: C17101
• Date Manufacturer Received: 01/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention