COOK TPN SINGLE LUMEN CATHETER REPAIR SET
Report
- Report Number
- 1820334-2020-01438
- Event Type
- Injury
- Date Received
- August 5, 2020
- Date of Event
- June 22, 2020
- Report Date
- September 30, 2020
- Manufacturer
- COOK INC
- Product Code
- DQY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION - EVALUATION. IT WAS REPORTED BY UMC GRONINGEN IN THE NETHERLANDS THAT ¿THE METAL CANNULA CAME LOOSE AND SHIFTED.¿ A 56-YEAR-OLD MALE PATIENT HAD A COMPETITOR CATHETER PLACED IN HIS RIGHT SUBCLAVIAN VEIN ON (B)(6)2019 FOR ADMINISTRATION OF SALINE SOLUTION AND HOME PARENTERAL NUTRITION (HPN). THE DEVICE WAS NOTED TO HAVE A HOLE IN THE LINE. ON (B)(6)2020, THE PATIENT REQUIRED THE USE OF A COOK TPN SINGLE LUMEN CATHETER REPAIR SET (RPN: C-RHCS-6.5) TO ASSIST IN REPAIRING THE CATHETER. THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT CONTINUED RECEIVING TREATMENTS. HOWEVER, ON 22JUN2020, IT WAS REPORTED THE METAL CANNULA OF THE REPAIR SET HAD ¿COME LOOSE AND HAD SLIPPED THROUGH.¿ ON THE LEFT SIDE OF THE DEVICE, THE RUBBER PORTION OF THE REPAIR WAS ¿STILL STUCK¿; HOWEVER, ON THE RIGHT SIDE OF THE DEVICE, THE METAL CANNULA COULD BE SEEN. THE PATIENT HAD THE DEVICE REMOVED AT THE HOSPITAL AND AN EXCHANGE PROCEDURE WAS PERFORMED. A NEW CATHETER WAS INTRODUCED INTO THE RIGHT SUBCLAVIAN VEIN. HOWEVER, DURING THE PROCEDURE, THE WIRE GUIDE SEPARATED IN THE PATIENT, WHICH IS REPORTED UNDER MDR REF. #1820334-2020-01439. THE FRAGMENTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. IT WAS REPORTED THE PATIENT WAS ADMITTED TO HOSPITAL FOR A ¿FEW DAYS¿ OF ADMINISTRATION OF FLUIDS. NO OTHER ADVERSE EVENTS WERE REPORTED. A REVIEW OF THE 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. THE CUSTOMER REPORTED THAT THE DEVICE WAS LIKELY FROM EITHER LOT 10311317 OR LOT 10222175. REVIEWS OF THE DHRS FOR BOTH LOTS AND THEIR RELATED REPAIR SECTION SUB-ASSEMBLY LOTS REVEALED NO RECORDED NON-CONFORMANCES RELATED TO THE FAILURE MODE. A DATABASE SEARCH FOUND NO OTHER EVENTS ASSOCIATED WITH EITHER DEVICE LOT. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE INSTRUCTIONS FOR USE PACKAGING WITH THE DEVICE STATES THE FOLLOWING IN REGARDS TO THE FAILURE MODE: "CUT OFF THE DAMAGED PORTION OF THE CATHETER. THE REPLACEMENT CATHETER END HAS A PRELOADED METAL CANNULA. APPLY ADHESIVE TO THE METAL CANNULA. INSERT THE METAL CANNULA INTO THE EXISTING CATHETER LUMEN WITH A TWISTING MOTION. SLIDE THE EXISTING CATHETER OVER THE METAL CANNULA UNTIL IT IS FLUSH WITH THE REPLACEMENT CATHETER TUBING. APPLY ADHESIVE TO THE JUNCTION. SLIDE THE SLEEVE OVER THE JUNCTION. INJECT ADHESIVE INTO BOTH ENDS OF THE SLEEVE AND WIPE OFF THE EXCESS ADHESIVE IMAGES OF THE STEPS ARE PROVIDED WITH THE INSTRUCTIONS." BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE FOR THIS EVENT COULD NOT BE ESTABLISHED. IT IS POSSIBLE THAT PATIENT MOVEMENT/ACTIVITY INADVERTENTLY CAUSED TENSION AND PULLING ON THE DEVICE, CONTRIBUTING TO ITS FAILURE. ADDITIONALLY, IMPROPER SECUREMENT AND INADVERTENT TENSION DURING FLUSHING AND FLUID ADMINISTRATION COULD HAVE CONTRIBUTED TO FAILURE OF DEVICE. 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.
IN ADDITIONAL INFORMATION RECEIVED ON 21AUG2020, IT WAS CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE DEVICE WAS PLACED ON (B)(6) 2019 IN THE RIGHT SUBCLAVIAN VEIN FOR THE ADMINISTRATION OF SALINE SOLUTION BEFORE HPN WAS DELIVERED. THE FAILURE OCCURRED DURING TREATMENT WITH HPN ON (B)(6) 2020. TAUROSEPT 2% WAS USED TO MAINTAIN THE CATHETER, AND THE NURSE HELD THE LINE TO SECURE WHILE ADMINISTERING THE SALINE SOLUTION BEFORE HPN. IT WAS REPORTED THAT THE PATIENT WAS ABLE TO PARTICIPATE IN THE ACTIVITIES OF DAILY LIVING. THE MIGRATED METAL CANNULA WAS CONFIRMED TO BE FROM THE CATHETER REPAIR ON (B)(6) 2020. THE GLUE WAS APPLIED TO THE METAL CANNULA AND INTO THE SILICONE SLEEVE DURING THE REPAIR. THE LOT NUMBER FOR THE DEVICE IS UNKNOWN, BUT COULD POSSIBLY BE EITHER 10311317 OR 10222175. THE THREE REPAIRS A YEAR THAT WERE REPORTED BY THE CUSTOMER WERE IN REFERENCE TO EXPECTED REPAIRS.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
PRODUCT LOT #: CUSTOMER HAS STATED THAT THE LOT # IS "PROBABLY 10311317 OR 10222175 BUT NOT SURE." PMA/510(K) #: PREAMENDMENT. THE PATIENT REQUIRED HOSPITALIZATION AS WELL AS AN ADDITIONAL PROCEDURE TO REMOVE AND REPLACE THE DEVICE TO PRECLUDE PERMANENT IMPAIRMENT/DAMAGE. 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 THE METAL CANNULA OF A COOK TPN SINGLE LUMEN CATHETER REPAIR SET CAME LOOSE AND SHIFTED. THE (B)(6) YEAR-OLD MALE PATIENT CALLED THE USER FACILITY'S TECHNICAL NUTRITION TEAM ON (B)(6) 2020 DUE TO A HOLE IN HIS "CVK (HICKMAN CATHETER, SIZE 6.5 FR)"'. THE LINE WAS ABLE TO BE REPAIRED USING A COOK TPN SINGLE LUMEN CATHETER REPAIR SET. HOWEVER, FOUR MONTHS LATER ON THE MORNING OF (B)(6) 2020, THE PATIENT AND HOME CARE WORKER WHO HAD COME TO "DISCONNECT THE TPV" BOTH NOTICED THAT THE METAL CANNULA OF THE REPAIR SET HAD "COME LOOSE AND HAD SLIPPED THROUGH". IT WAS REPORTED THAT ON THE LEFT OF THE DEVICE, THE RUBBER PORTION THAT HAD PREVIOUSLY BEEN PUSHED OVER THE INITIAL DEFECT WAS "STILL STUCK" ACCORDING TO BOTH THE PATIENT AND HOME CARE. ON THE RIGHT SIDE OF THE DEVICE, THE METAL CANNULA CAN BE SEEN. THE PATIENT CLAMPED THE LINE AND WENT TO THE HOSPITAL WHO CONFIRMED THAT THE METAL CANNULA IS ABLE TO BE FELT AND SEEN DOWN THE LINE. CONSEQUENTLY, THE SURGEON EXCHANGED THE LINE OVER A GUIDEWIRE AFTER CUTTING AND REMOVING THE TUNNELED METAL CANNULA PORTION. THE PATIENT WAS ADMINISTERED A LOCAL ANESTHETIC AND AN INCISION WAS MADE AT THE INSERTION SITE. BLUNT PREPARATION OF THE CATHETER WAS PERFORMED. A WIRE GUIDE WAS INTRODUCED TO THE CATHETER IN THE RIGHT SUBCLAVIAN VEIN AND THE CATHETER WAS MOSTLY REMOVED. DURING EXCHANGING THE CVC, A PART OF THE HICKMAN CATHETER AND WIRE GUIDE SEPARATED AND WERE LEFT INTRALUMINAL IN THE PATIENT, WHICH IS ALSO REPORTED UNDER PATIENT IDENTIFIER (B)(6) . THE USER FACILITY'S INTERVENTION RADIOLOGY DEPARTMENT REMOVED THE FRAGMENTS FROM THE PATIENT USING THE FEMORAL VEIN. A NEW DEVICE WAS INTRODUCED IN THE RIGHT SUBCLAVIAN VEIN AND PLACED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A "FEW DAYS" OF ADMINISTRATION OF FLUIDS WITH NO POSSIBILITY OF ADMINISTRATION OF TPN. ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 834697 | COOK TPN SINGLE LUMEN CATHETER REPAIR SET | DQY CATHETER, PERCUTANEOUS | DQY | COOK INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |