inforMED
InjuryGDM

HAWKINS II FLEXSTRAND BLN 20GA X 10CM

Received Jan 17, 2022 · Event occurred Dec 3, 2021

Report 0001625425-2022-00930 · MDR key 13267124

Device

Generic name

Hawkins Ii Flexstrand Bln

Model number

252100

Lot number

11373483

Product problems

  • Difficult to Remove
  • Mechanical Jam

Patient

Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Additional Manufacturer Narrative

THE SAMPLE IS INDICATED AS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN RECEIVED AND REVIEWED.

Description of Event or Problem

WE HAVE SEVERAL OCCURRENCES WHEN USING THE 10CM NEEDLE WITH WIRE WHERE WE COULD NOT REMOVE THE NEEDLE OFF OF THE WIRE, IT GETS STUCK THE RADIOLOGIST HAD TO PULL WITH A LOT F FORCES TO REMOVE IT, IN A RECENT PROCEDURE IT GOT STUCK TO THE POINT THAT THEY COULD NOT REMOVE THE NEEDLE AND SENT THE PATIENT TO SURGERY WITH THE NEEDLE AND WIRE IN THE BREAST AS FAR AS I KNOW THIS HAS NOT HAPPENED WITH THE 5CM OR 12.5 NEEDLE WITH WIRE

Additional Manufacturer Narrative

A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND ALTHOUGH A TEMPORARY DEVIATION NOTICE WAS GIVEN, THERE IS NO EVIDENCE THAT IT CONTRIBUTES TO THE COMPLAINT. IT WAS NOT NECESSARY TO CHECK ANY OTHER DOCUMENTATION IN THE COURSE OF INVESTIGATING THIS COMPLAINT. A FUNCTIONAL ANALYSIS OF THE RETURNED SAMPLE WAS CONDUCTED, AND THE FOLLOWING FINDINGS ARE RELEVANT TO THE COMPLAINT: THE PRODUCT WAS NOT DAMAGED OR MISSING COMPONENTS. EXCESSIVE RESISTANCE WAS FELT. THE RETURNED GUIDEWIRE WAS USED TO PASS THROUGH THE NEEDLE OF THE SAMPLES. THERE WAS EXCESSIVE RESISTANCE FELT AS THE GUIDEWIRE MOVED THROUGH THE CANNULA. THIS IS OUTSIDE OF ARGON SPECIFICATION (NEEDLE MUST BE ABLE TO PASS THROUGH THE CANNULA). THEREFORE, THE COMPLAINT IS CONFIRMED. SINCE THE MANUFACTURE OF THIS LOT, TDN 120646 WAS ISSUED TO CORRECT THE STACK UP TOLERANCES ON OUR CURRENT DRAWINGS FOR THE TIME BEING. THE DRAWING USED (DWG-1280021-X) IS CURRENTLY BEING UPDATED WITH THE NEW TOLERANCES TO MAKE THESE CHANGES PERMANENT.

Description of Event or Problem

WE HAVE SEVERAL OCCURRENCES WHEN USING THE 10CM NEEDLE WITH WIRE WHERE WE COULD NOT REMOVE THE NEEDLE OFF OF THE WIRE, IT GETS STUCK THE RADIOLOGIST HAD TO PULL WITH A LOT F FORCES TO REMOVE IT, IN A RECENT PROCEDURE IT GOT STUCK TO THE POINT THAT THEY COULD NOT REMOVE THE NEEDLE AND SENT THE PATIENT TO SURGERY WITH THE NEEDLE AND WIRE IN THE BREAST AS FAR AS I KNOW THIS HAS NOT HAPPENED WITH THE 5CM OR 12.5 NEEDLE WITH WIRE.

Additional Manufacturer Narrative

THE SAMPLE IS INDICATED AS RETURNED. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN EVALUATED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN REVIEWED.

Description of Event or Problem

WE HAVE SEVERAL OCCURRENCES WHEN USING THE 10CM NEEDLE WITH WIRE WHERE WE COULD NOT REMOVE THE NEEDLE OFF OF THE WIRE, IT GETS STUCK THE RADIOLOGIST HAD TO PULL WITH A LOT F FORCES TO REMOVE IT, IN A RECENT PROCEDURE IT GOT STUCK TO THE POINT THAT THEY COULD NOT REMOVE THE NEEDLE AND SENT THE PATIENT TO SURGERY WITH THE NEEDLE AND WIRE IN THE BREAST AS FAR AS I KNOW THIS HAS NOT HAPPENED WITH THE 5CM OR 12.5 NEEDLE WITH WIRE.