COOK SPECTRUM
Report
- Report Number
- 1820334-2020-00107
- Event Type
- Malfunction
- Date Received
- January 14, 2020
- Date of Event
- December 27, 2019
- Report Date
- March 4, 2020
- Manufacturer
- COOK INC
- Product Code
- FOZ
- UDI-DI
- 00827002515376
- PMA / PMN Number
- K081113
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
H6- METHOD CODE: ADDITIONAL METHOD CODES: ANALYSIS OF PRODUCTION RECORDS (3331), DEVICE NOT RETURNED (4114). INVESTIGATION - EVALUATION: IT WAS REPORTED TO COOK THAT THE WIRE GUIDE WITHIN A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED FIVE LUMEN CENTRAL VENOUS CATHETER SET, C-UQLM-1001J-ABRM-HC-RD, FROM LOT # 9938184, HAD RESISTANCE DURING REMOVAL, WHICH CAUSED THE WIRE TO UNRAVEL. THIS INCIDENT WAS REPORTED BY MIDDLEMORE HOSPITAL, IN NEW ZEALAND, ON 08JAN2020. THE DEVICE WAS REMOVED, AND ANOTHER WAS PLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED. A REVIEW OF THE DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, THE USER FACILITY PROVIDED TWO IMAGES OF THE DEVICE WHICH SHOWED ONE KINKED SECTION AND ONE UNRAVELED SECTION. THE IMAGES SHOW NO EVIDENCE OF THE DEVICE BEING MANUFACTURED OUT OF SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE DESIGN HISTORY FILE (DHF) FOUND THAT THE AFFECTED PRODUCT MEETS ITS ESTABLISHED ACCEPTANCE CRITERION AND IS BOTH SAFE AND EFFECTIVE FOR ITS INTENDED USE. THE DHRS FOR THE REPORTED COMPLAINT DEVICE LOT (9938184) AND RELATED SUB-ASSEMBLY LOTS REVEALED ONE RECORDED NON-CONFORMANCE FOR "BENT/KINKED" IN WHICH ONE DEVICE WAS SCRAPPED. A DATABASE SEARCH FOUND THIS TO BE THE ONLY EVENT ASSOCIATED WITH THE REPORTED DEVICE LOT. FURTHERMORE, THERE IS NO EVIDENCE SUGGESTING THAT NONCONFORMING PRODUCT FROM THIS LOT EXISTS IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, ¿COOK SPECTRUM CENTRAL VENOUS CATHETER MINOCYCLINE/RIFAMPIN ANTIBIOTIC IMPREGNATED POWER INJECTABLE,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: INSTRUCTIONS FOR USE: ¿4. SLIDE SAFE-T-J WIRE GUIDE STRAIGHTENER (POSITIONED ON DISTAL TIP OF WIRE GUIDE) OVER ¿J¿ PORTION OF WIRE GUIDE. PASS STRAIGENED WIRE GUIDE THROUGH NEEDLE; ADVANCE WIRE GUIDE 5-10 CM INTO VESSEL. IF STRAIGHT WIRE IS USED, ALWAYS ADVANCE SOFT, FLEXIBLE END THROUGH NEEDLE HUB AND INTO VESSEL. IF RESISTANCE IS ENCOUNTERED DURING WIRE GUIDE INSERTION, DO NOT FORCE WIRE GUIDE. WITHDRAWAL OF WIRE GUIDE THROUGH NEEDLE SHOULD BE AVOIDED; BREAKAGE MAY RESULT. 5. WHILE MAINTAINING WIRE GUIDE POSITION, WITHDRAW NEEDLE AND SAFE-T-J WIRE GUIDE STRAIGHTENER.¿ HOW SUPPLIED: ¿SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE WAS TRACED TO COMPONENT FAILURE WITHOUT A DESIGN OR MANUFACTURING ISSUE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
NO ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
DEVICE NAME: COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED FIVE LUMEN CENTRAL VENOUS CATHETER SET. PRODUCT LOT: LOT IS EITHER 980766 OR 9938184. (B)(6). OCCUPATION: REGULATORY AFFAIRS SPECIALIST. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING WITHDRAWAL OF THE WIRE GUIDE IN A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED FIVE LUMEN CENTRAL VENOUS CATHETER SET DURING A CVC REPLACEMENT. THE LINE WAS INSERTED INTO THE RIGHT AXILLARY/SUBCLAVIAN REGION OF A BURN PATIENT AFTER AN OPERATIVE PROCEDURE. THE VESSEL WAS REPORTED TO BE DILATED. RESISTANCE WAS NOTED AT APPROXIMATELY 20 CM AND THE CATHETER WAS UNABLE TO BE PASSED OVER THE GUIDE WIRE. WHEN THE WIRE WAS BEING WITHDRAWN, UNCOILING IN THE WIRE WAS NOTED. ULTIMATELY, THE INSERTION WAS ABANDONED AND MOVED TO THE OTHER SIDE. THE VASCULAR TEAM REMOVED THE GUIDE WIRE SUCCESSFULLY AND THE PATIENT WAS TAKEN TO THE ICU. EXTUBATION WAS DELAYED TO "ENSURE THAT THE PATIENT DID NOT COUGH OR STRAIN CAUSING BLEEDING". NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. THE PRODUCT WILL NOT BE RETURNED, AS IT HAS BEEN DISCARDED BY THE FACILITY "DUR" TO CONTAMINATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 51717 | COOK SPECTRUM | FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS | FOZ | COOK INC | G51537 | 9938184 | 00827002515376 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR |