inforMED
MalfunctionIQE

INFANT/CHILD LUMBAR 22G 1 1/2 NDL

Received Aug 31, 2001 · Event occurred Jul 16, 2001

Report 1018381-2001-00073 · MDR key 350439

Device

Generic name

Procedural Tray

Model number

NA

Catalog number

04824, 04826, 04827

Lot number

UNK

Product problems

  • Fluid/Blood Leak

Patient

Not reported

  • No Consequences Or Impact To Patient
  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

REPORT RECEIVED OF AN UNDOCUMENTED NUMBER OF UNDOCUMENTED INCIDENTS OF THE COLLECTION TUBE LEAKING. THE CUSTOMER REPORTS THAT VIRAL CULTURES ARE SENT TO AN OFF-SITE LABORATORY. THE TUBES ARE PUT INTO A TRANSPORT BAG AND COOLER. WHEN THE TUBES ARRIVE AT THE OFF-SITE LAB IT HAS BEEN REPORTED THAT THE FLUID HAS LEAKED OUT OF THE TUBE AND INTO THE BAG. THE TUBES ARE INTACT AND THE LIDS ARE INTACT, BUT THE FLUID IS IN THE BAG. THERE HAVE BEEN REPORTS WHERE SOME OF THE PATIENTS HAVE NEEDED TO BE RE-STUCK FOR ADDITIONAL SPECIMEN COLLECTION. THERE HAVE BEEN NO REPORTS OF ADVERSE PATIENT EVENTS. ADD'L PT INFO WAS REQUESTED, BUT NO FURTHER INFO WAS AVAILABLE.