| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SPECTRUM VENTRICLEAR DRAINAGE CATHETER SET | CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS) | COOK, INC. | NHC | NA | N-VVDC-01-ABRM | UNK | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-03-04 | 0 | 1. D |
Patient 1
THE PATIENT HAD A VENTRICULAR DRAIN PLACED ON (B)(6) 2014 FOR TREATMENT OF A BRAIN HEMORRHAGE. AFTERWARDS, THE PATIENT DEVELOPED A FEVER ON (B)(6)2014. THE PATIENT'S CSF TESTED POSITIVE FOR SERRATIA ON (B)(6)2014. THE EXTERNAL DRAIN WAS REMOVED ON (B)(6)2014. THE PATIENT PASSED AWAY DUE TO COMPLICATIONS OF MENINGITIS AND BRAIN BLEED ON (B)(6)2015. WHEN THE DEVICE WAS CULTURED IT WAS POSITIVE AT THE SHUNT AND AT THE END OF THE DRAIN.
Patient 1
(B)(4). A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL (QC) WAS PERFORMED FOR THE PURPOSE OF THIS INVESTIGATION. PER INFORMATION SUPPLIED BY THE CUSTOMER, NO PRODUCT WILL BE RETURNED. QUALITY CONTROL CONFIRMS THE CATHETER SURFACE IS FREE OF DAMAGE, DIRT AND FOREIGN DEBRIS. THERE IS NO EVIDENCE TO SUGGEST THAT THE CATHETER WAS NOT MANUFACTURED PER SPECIFICATIONS. THIS PRODUCT IS SHIPPED WITH AN IFU WHICH STATES UNDER PRECAUTIONS: "THE CATHETER SHOULD NOT COME INTO CONTACT WITH ETHYL ALCOHOL, ISOPROPYL ALCOHOL, OR OTHER ALCOHOLS, ACETONE OR OTHER NON-POLAR SOLVENTS. THESE SOLVENTS MAY REMOVE THE ANTIMICROBIALS FROM THE CATHETER AND REDUCE THE CATHETER'S ANTIMICROBIAL ACTIVITY"./ INSTRUCTIONS FOR USE: "ENSURE THE CATHETER REMAINS CAPPED OR CONNECTED TO A STERILE DRAINAGE SYSTEM AT ALL TIMES. ALL CATHETER OR PATIENT MANIPULATIONS AND FLUID DRAINAGE SYSTEM CHANGES MUST BE CARRIED OUT UTILIZING STRICT STERILE TECHNIQUE TO REDUCE THE RISK OF CATHETER-RELATED INFECTIONS". WE ARE INCONCLUSIVE AS TO WHY THE FAILURE MODE OCCURRED. QUALITY ENGINEERING RISK ASSESSMENT WAS USED TO ASSESS THE RISK OF THE EVENT. PER THE CONCLUSION OF THE RISK ASSESSMENT, NO FURTHER RISK REDUCTION IS REQUIRED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.