COOK SPECTRUM
Report
- Report Number
- 1820334-2020-01788
- Event Type
- Malfunction
- Date Received
- October 1, 2020
- Date of Event
- September 11, 2020
- Report Date
- November 18, 2020
- Manufacturer
- COOK INC
- Product Code
- FOZ
- UDI-DI
- 00827002478299
- PMA / PMN Number
- K081113
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- PHYSICIAN
Narratives
INVESTIGATION - EVALUATION: IT WAS REPORTED THAT A CRACK WAS FOUND ON THE WHITE HUB OF THE CATHETER FROM A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET (C-UTLM-701J-RSC-ABRM-HC-RD) FROM LOT 9676480. THIS CRACK WAS NOTED FOLLOWING IMPLANTATION AFTER UNSCREWING A SCREW CAP WHICH WAS USED TO LOCK THE LUMEN. COOK BECAME AWARE OF THIS EVENT ON 22SEP2020 UPON BEING NOTIFIED BY NATIONAL CHENG KUNG UNIVERSITY HOSPITAL. THE PATIENT REPORTEDLY EXPERIENCED NO ADVERSE EFFECTS AS A RESULT OF THIS INCIDENT. A REVIEW OF 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, 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. A REVIEW OF THE DESIGN HISTORY FILE (DHF) SHOWED THAT THIS DEVICE IS BOTH SAFE AND EFFECTIVE FOR ITS INTENDED USE. A REVIEW OF THE DHRS FOR THE REPORTED COMPLAINT DEVICE LOT (9676480) AND THE RELATED CATHETER SUBASSEMBLY LOT REVEALED NO RECORDED NON-CONFORMANCES. A DATABASE SEARCH FOUND ONE OTHER EVENT ASSOCIATED WITH THE REPORTED DEVICE LOT CONCERNING AN UNRELATED FAILURE MODE. AS THERE ARE NO RELATED NON-CONFORMANCES OR OTHER COMPLAINTS FOR THE SAME FAILURE MODE FROM THIS LOT, THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN THE FIELD. ADDITIONALLY, COOK HAS CONCLUDED THAT THIS DEVICE WAS MANUFACTURED TO SPECIFICATION. COOK ALSO REVIEWED PRODUCT LABELING. INSTRUCTIONS FOR USE (IFU) DOCUMENT [COOK SPECTRUM CENTRAL VENOUS CATHETER MINOCYCLINE/RIFAMPIN ANTIBIOTIC IMPREGNATED POWER INJECTABLE] IS PACKAGED WITH THIS DEVICE. THE PRODUCT IFU STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: ¿WARNINGS: THE SAFE AND EFFECTIVE USE OF CENTRAL VENOUS CATHETERS WITH POWER INJECTOR PRESSURES (SAFETY CUT-OFF) SET ABOVE 325 PSI HAS NOT BEEN ESTABLISHED. DO NOT POWER INJECT IF MAXIMUM INJECTION RATE CANNOT BE VERIFIED TO MEET LIMIT OF 10 ML/SEC. TO SAFELY USE CATHETERS WITH A POWER INJECTOR, THE TECHNICIAN/HEALTHCARE PROFESSIONAL MUST VERIFY PRIOR TO USE THAT THE MAXIMUM SAFETY CUT-OFF PRESSURE LIMIT IS SET AT OR BELOW 325 PSI AND THAT THE MAXIMUM FLOW RATE IS AT OR BELOW 10 ML/SEC. POWER INJECTION PROCEDURE: WARNING: FAILURE TO ENSURE PATENCY OF THE CATHETER LUMEN PRIOR TO INJECTION MAY RESULT IN CATHETER FAILURE. HOW SUPPLIED: 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 COULD NOT BE ESTABLISHED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. APPROPRIATE MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE; A CAPA IS CURRENTLY OPEN TO ADDRESS THIS FAILURE MODE IN RELATION TO THESE DEVICES. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION WAS PROVIDED ON 05OCT2020 INDICATING THAT A "SCREW CAP WHICH USED TO LOCK THE LUMEN" WAS CONNECTED TO THE CRACKED HUB.
DEVICE NAME: COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET. 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 A CRACK WAS FOUND ON THE "CONNECTOR OF [THE] WHITE PORT" OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET. THE CRACK WAS NOTICED FOLLOWING THE PROCEDURE. THE DEVICE WAS PLACED THROUGH THE PATIENT'S VENA SUBCLAVIAN. NO ADVERSE EFFECTS HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING THE DEVICE HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1076907 | COOK SPECTRUM | FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS | FOZ | COOK INC | G47829 | 9676480 | 00827002478299 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |