IT WAS REPORTED VIA MEDWATCH THAT A DRAIN BROKE UPON REMOVAL. THE DRAIN WAS PLACED IN A PT ON (B)(6) 2011 WHO HAD UNDERGONE A SCHEDULED SURGICAL PROCEDURE FOR A LEFT HIP REPLACEMENT DUE TO DJD AND MORBID OBESITY. THE DRAIN WAS REMOVED BY THE NURSE PER PHYSICIAN ORDER ON (B)(6) 2011. THE NURSE DID NOT NOTE ANY RESISTANCE UPON REMOVAL. AT A F/U VISIT AT THE PHYSICIAN'S OFFICE ON (B)(6) 2011, AN XRAY CONFIRMED THAT A PIECE OF DRAIN WAS RETAINED IN THE LEFT HIP. ON (B)(6) 2011, THE PIECE WAS SURGICALLY REMOVED W/O ANY PROBLEMS. THE PT WAS KEPT IN THE HOSPITAL OVERNIGHT AS A PRECAUTION.
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Patient 1
PHOTOGRAPHIC IMAGES OF THE ACTUAL SAMPLE WERE RETURNED BY THE CUSTOMER IN-LIEU OF THE ACTUAL PHYSICAL SAMPLE. THE FACILITY DID NOT RELEASE THE ACTUAL SAMPLE DUE TO INTERNAL POLICIES AND PROCEDURES. VISUAL EVAL OF THE PHOTOGRAPHS NOTED THAT THE DRAIN WAS BROKEN AT THE TRANSITION SECTION WHERE THE DRAIN AND CONNECTOR MEET. NO FUNCTIONAL OR DIMENSIONAL VALUE TESTING COULD BE PERFORMED W/O THE ACTUAL SAMPLE. 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. IN ADDITION, THIS PRODUCT CODE IS REC'D FROM AN EXTERNAL SUPPLIER WHO CERTIFIES THAT THE PRODUCT HAS BEEN MANUFACTURED ACCORDING TO BARD SPECIFICATIONS. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING PRECAUTIONS "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).