inforMED
MalfunctionFCH

UCH CUSTOM BLOCK TRAY

Received May 9, 2013 · Event occurred May 3, 2013

Report MW5030153 · MDR key 3114072

Device

Generic name

Block Tray

Model number

2581

Lot number

1330075

Product problems

  • Device Damaged Prior to Use
  • Device Contamination with Chemical or Other Material

Patient

Not reported

  • No Patient Involvement

Narrative

Description of Event or Problem

(B)(6) HEALTH CUSTOM BLOCK TRAY, CAT #: BUSSE 2582, LOT #: 1330075. COMPLAINT NUMBER FILED WITH (B)(4). TRAY WAS OPENED TO USE IN PT PROCEDURE AND NOTED TO HAVE SMALL BLACK "THINGS" IN THE BARREL OF THE SYRINGE. THE "THINGS" WHEN LOOKED AT UNDER A MAGNIFYING GLASS LOOKED TO BE FLEAS. THIS PRODUCT NEVER REACHED THE PT, AND ALL PRODUCT WITH THIS LOT NUMBER WERE PULLED. THIS PRODUCT IS BEING RETURNED TO (B)(4) HOSP DISPOSABLES FOR EVAL AND REPORT.