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MEDICHOICE UMBILICAL CORD CLAMP

Received Oct 18, 2005 · Event occurred Aug 26, 2005

Report 1046367-2005-00002 · MDR key 642380

Device

Generic name

Umbilical Cord Clamp

Model number

NA

Catalog number

88101

Lot number

UNK

Product problems

  • Replace

Patient

0 DAY

  • Bleeding

Narrative

Description of Event or Problem

FOLLOWING PATIENT DELIVERY, THE UMBILICAL CORD WAS CLAMPED AND CUT AS USUAL. WHEN APPLYING THE CORD CLAMP, IT WAS STATED THAT THEY ATTACHED A TRANSPONDER TO THE PT USING THE CORD CLAMP. AT CHANGE OF SHIFT ASSESSMENT, A NURSE NOTED BLOOD OOZING FROM THE CORD; THEREFORE, A NEW CORD CLAMP WAS ATTACHED AND THE BLEEDING STOPPED. NO COMPLICATIONS OR INJURIES TO THE PT WERE REPORTED. WHEN THE ORIGINAL CLAMP WAS INSPECTED, THE USER FACILITY REPORTED THAT IT APPEARED TO BE "SLIGHTLY BOWED." THE USER FACILITY ALSO INDICATED THAT THE NURSES WERE NOT CERTAIN IF THE TRANSPONDER WAS PROPERLY ALIGNED IN THE CLAMP. THE NURSES REPORTED THAT THEY "HAVE NOT HAD A SIMILAR EXPERIENCE IN THE YEAR-PLUS FACILITY HAS BEEN USING THIS CLAMP."