inforMED
MalfunctionDRC

WINGED GUIDEWIRE INTRODUCER NEEDLE 18GA X 7CM

Received Jul 6, 2026

Report 0001625425-2026-00982 · MDR key 25713303

Device

Generic name

Trocar

Model number

BGWI1802

Lot number

11625460

Product problems

  • Dull, Blunt

Patient

NA · Unknown

  • Syncope/Fainting

Narrative

Additional Manufacturer Narrative

IT IS UNKNOWN IF THE SAMPLE IS AVAILABLE. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.

Description of Event or Problem

PERFORATION OF THE BLOOD VESSEL CAUSED BY A BLUNT NEEDLE TIP. AS A RESULT, THE PATIENT EXPERIENCED A VAGAL REACTION ACCOMPANIED BY SYNCOPE. DOCTORS COMMENT: THE NEEDLE TIP IS NOT SHARP ENOUGH, WHICH MEANS IT IS SOMETIMES NOT POSSIBLE TO PUNCTURE THE JUGULAR VEIN.