inforMED
MalfunctionMMP

GAMMA FINDER III STERILE SLEEVE

Received Jul 31, 2024 · Event occurred Apr 10, 2024

Report 19873455 · MDR key 19873455

Device

Generic name

Cover, Barrier, Protective

Catalog number

1031

Lot number

76673

Product problems

  • Fluid/Blood Leak
  • Device Contamination with Body Fluid
  • Material Integrity Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

AFTER THE CASE, THE GAMMA FINDER PROBE WAS GETTING WIPED OFF AND OBSERVED THAT THE TIP OF THE PROBE WAS COATED WITH BLOOD AFTER THE PROBE COVER WAS REMOVED AND HAD BEEN THROWN AWAY. WE WERE UNABLE TO OBTAIN THE USED PROBE COVER TO ASSESS FOR HOLES. NO PATIENT HARM.

Additional Manufacturer Narrative

THE FOLLOWING ELEMENTS HAVE BLANK DATA: [DEVICE MANUFACTURER'S STREET ADDRESS: (LINE 1)] FOR TYPE OF DEVICE: PROBE, UPTAKE, NUCLEAR [CITY:] FOR TYPE OF DEVICE: PROBE, UPTAKE, NUCLEAR [STATE:] FOR TYPE OF DEVICE: PROBE, UPTAKE, NUCLEAR [ZIP:] FOR TYPE OF DEVICE: PROBE, UPTAKE, NUCLEAR.

Description of Event or Problem

AFTER THE CASE, THE GAMMA FINDER PROBE WAS GETTING WIPED OFF AND OBSERVED THAT THE TIP OF THE PROBE WAS COATED WITH BLOOD AFTER THE PROBE COVER WAS REMOVED AND HAD BEEN THROWN AWAY. WE WERE UNABLE TO OBTAIN THE USED PROBE COVER TO ASSESS FOR HOLES. NO PATIENT HARM.

Description of Event or Problem

AFTER THE CASE, THE GAMMA FINDER PROBE WAS GETTING WIPED OFF AND OBSERVED THAT THE TIP OF THE PROBE WAS COATED WITH BLOOD AFTER THE PROBE COVER WAS REMOVED AND HAD BEEN THROWN AWAY. WE WERE UNABLE TO OBTAIN THE USED PROBE COVER TO ASSESS FOR HOLES. NO PATIENT HARM.