inforMED
MalfunctionGIO

CLEAR-CRIT PLASTIC CAPILLARY TUBES

Received Oct 28, 1999 · Event occurred Oct 6, 1999

Report MW1017436 · MDR key 247147

Device

Generic name

Capillary Tubes

Model number

NA

Catalog number

270-106

Lot number

11208-06079-1239

Product problems

  • Filling Problem
  • Mislabeled
  • Off-Label Use
  • Inadequacy of Device Shape and/or Size
  • Low Readings

Patient

*

  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

A FINGERSTICK PUNCTURE WAS PERFORMED ON A POTENTIAL BLOOD DONOR. A SAMPLE OF BLOOD WAS TO BE OBTAINED TO DETERMINE THE DONOR'S HEMATOCRIT. THE CAPILLARY TUBES DID NOT APPEAR TO FILL WITH BLOOD IN A ROUTINE MANNER. THE HEMATOCRIT VALUE OBTAINED FOR THE DONOR WAS ONLY 24%. FURTHER INVESTIGATION REVEALED THAT THE INSIDE DIAMETER(ID) OF THE CAPILLARY TUBES IN THE SLEEVES(VIALS) WAS ONLY 0.5MM INSTEAD OF 1.1MM. THE VIALS WERE LABELED AS CONTAINING 1.1MM(ID) TUBES. ANOTHER HEMATOCRIT DETERMINATION WAS PERFORMED ON THE DONOR WITH 1.1MM(ID) TUBES AND THE RESULT OBTAINED WAS 37% AS COMPARED TO THE PREVIOUS RESULT OF 24%. RPTR RETRIEVED 8 BOXES OF CAPILLARY TUBES(200 TUBES/VIAL) AND EACH BOX HAD 1 VIAL OF TUBES, 0.5MM(ID) AND THE VIAL WAS LABELED AS CONTAINING 1.1MM(ID) TUBES. ALL OTHER VIALS CONTAINED TUBES 1.1(ID) IN APPROPRIATELY LABELED VIALS. THE MFR WAS NOTIFIED.