IT WAS REPORTED VIA MAUDE EVENT REPORT THAT A PATIENT WITH STATUS POST COMPLEX CERVICAL DISKECTOMY WITH SPINAL INSTRUMENTATION HAD A DRAIN PLACED. UPON REMOVAL FROM THE CERVICAL AREA BY THE NEUROSURGEON'S PA, THERE SEEMED TO BE A DEGREE OF TENSION AND THEN A BREAK WITH A PORTION OF THE DRAIN TUBING REMAINING IN THE ANTERIOR NECK. A CT OF THE CERVICAL SPINE CONFIRMED A SMALL RETAINED PORTION OF THE SPINE FROM C4 THROUGH C5. THE PATIENT WAS TAKEN TO SURGERY WHERE THE FRAGMENT WAS REMOVED WITHOUT ANY PROBLEMS. THE PATIENT WAS DISCHARGED WITH NO RESIDUAL EFFECTS RELATED TO THE EVENT.
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Patient 1
BARD HAS MADE THREE ATTEMPTS FOR ADDITIONAL INFORMATION AND TO OBTAIN THE SAMPLE FROM THE CUSTOMER. NO SAMPLE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AS A FINISHED GOOD, QA PERFORMS RANDOM VISUAL INSPECTIONS FOR DAMAGED COMPONENTS PRIOR TO PRODUCT RELEASE. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING PRECAUTIONS "ADDITIONAL PERFORATIONS SHOULD NOT BE MADE IN THE DRAIN. AVOID SUTURING THROUGH DRAIN. DRAIN SHOULD LIE FLAT AND IN LINE WITH THE SKIN EXIT AREAS. PARTICULAR CARE SHOULD BE TAKEN TO AVOID ANY OBSTACLES TO THE DRAIN EXIT PATH. DRAIN SHOULD BE CHECKED FOR FREE MOTION DURING CLOSURE TO MINIMIZE THE POSSIBILITY OF BREAKAGE. DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. DRAIN SHOULD NOT BE HANDLED WITH POINTED, TOOTHED OR SHARP INSTRUMENTS WHICH COULD CAUSE CUTS OR NICKS AND LEAD TO SUBSEQUENT STRUCTURAL FAILURE OF THE DRAIN. SURGICAL REMOVAL MAY BE NECESSARY IF DRAIN IS DIFFICULT TO REMOVE OR BREAKS." (B)(4).