| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BARD WOUND DRAIN | C.R. BARD, INC. | GCY | NA | 0070440 | UNK | N | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-05-14 | 0 | 1. R |
Patient 1
IT WAS REPORTED THAT A WOUND DRAIN PLACED INSIDE A PT DURING AN OPERATIVE PROCEDURE, BROKE AT PT'S BEDSIDE DURING THE REMOVAL ATTEMPT APPROX TWO DAYS LATER. MORE THAN ONE HALF OF THE DRAIN REMAINED INSIDE THE PT. THE PT RETURNED TO SURGERY FOR EXPLORATORY SURGERY TO REMOVE THE RETAINED DRAIN PORTION FROM THE PT'S ABDOMEN. DURING INITIAL PLACEMENT, THE DRAIN WAS NOT SUTURED. NO FURTHER COMPLICATIONS WERE REPORTED. ADD'L INFO HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED.
Patient 1
NO SAMPLE WAS RETURNED FOR INVESTIGATION. THE INCOMING QA RECORDS WERE REVIEWED FOR THE COMPONENT THAT IS USED IN THE PRODUCTION OF THIS PRODUCT AND THE RECORDS DID NOT SHOW ANY REJECTS RELATED TO TENSILE VALUES. ALL VALUES WITHIN THE LAST TWO YEARS WERE ABOVE THOSE SPECIFIED IN THE INTERNATIONAL STANDARD FOR SURGICAL DRAINS. THERE WAS NO EVIDENCE OF ANY MFG ISSUES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. THE INSTRUCTIONS STATE THE FOLLOWING PRECAUTIONS TO AVOID THE POSSIBILITY OF DRAIN DAMAGE OR BREAKAGE: AVOID SUTURING THROUGH DRAINS. DRAINS 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. DRAINS SHOULD BE CHECKED FOR FREE MOTION DURING CLOSURE TO MINIMIZE THE POSSIBILITY OF BREAKAGE. DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. DRAINS 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. A COMPLAINT HISTORY REVIEW FOUND NO INCREASED TRENDS ON THIS PRODUCT WITH THE SAME ISSUE. THIS PRODUCT HAS BEEN RECLASSIFIED AS EXEMPT FROM PREMARKET NOTIFICATION.