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BYRON CANDY CANE CANNULA

Received Nov 8, 2005 · Event occurred Oct 11, 2005

Report 2025576-2005-00001 · MDR key 645718

Device

Generic name

Aspiration Cannula

Manufacturer

Byron Medical

Model number

CCC 426L

Catalog number

CCC 426L

Lot number

LST

Product problems

  • Device, or device fragments remain in patient
  • Tip breakage

Patient

NA

  • Nonresorbable materials, unretrieved in body

Narrative

Description of Event or Problem

A ONE INCH PIECE OF CANNULA TIP BROKE OFF IN A PT DURING A PROCEDURE. THE DOCTOR WANTED THE PT TO HEAL FOR A MONTH, THEN HAVE HER X-RAYED TO DETERMINE THE EXACT LOCATION OF THE TIP FOR RETRIEVAL. UNTIL THEN THE REMAINING PORTION OF THE CANNULA WAS TO BE RETURNED FOR EVALUATION. ONCE THE TIP IS REMOVED IT IS TO BE RETURNED ALSO. THE DOCTORS OFFICE CALLED IN 2005 TO SAY THE PT DOES NOT WANT THE DOCTOR TO REMOVE THE TIP AND WILL SEEK ANOTHER FACILITY TO HAVE THE PIECE REMOVED. AS OF THIS REPORT THE CO WILL NOT RECEIVE ANY PIECES TO EVALUATE UNTIL FURTHER NOTICE FROM THE DOCTORS OFFICE.

Remedial action

  • Other