CXI SUPPORT CATHETER
Report
- Report Number
- 1820334-2022-00506
- Event Type
- Malfunction
- Date Received
- March 31, 2022
- Date of Event
- March 23, 2022
- Report Date
- August 11, 2022
- Manufacturer
- COOK INC
- Product Code
- KRA
- UDI-DI
- 00827002183735
- PMA / PMN Number
- K122796
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INITIAL REPORTER OCCUPATION: OCCUPATION = INVENTORY MANAGER. PMA/510(K) NUMBER = ALTHOUGH THE EXACT RPN IS UNKNOWN, THE POSSIBLE 510(K)S ARE K122796 OR K160884. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, DURING AN UNKNOWN PROCEDURE, A CXI SUPPORT CATHETER SEPARATED PRIOR TO USE. THE USER ATTEMPTED TO FLUSH THE DEVICE, HOWEVER, THE CATHETER WOULD NOT FLUSH. THE USER ADVANCED A WIRE TO CLEAR THE DEVICE, AND A RESIDUE REPORTEDLY CAME OUT OF THE CATHETER, WHICH THEN SEPARATED. ANOTHER CXI OF THE SAME TYPE WAS USED TO FINISH THE PROCEDURE, WITH NO FURTHER COMPLICATIONS. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION, DIMENSIONAL VERIFICATION, AND FUNCTIONAL TEST OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED. THE COMPLAINT DEVICE WAS RETURNED TO COOK. THE DEVICE WAS NOT SEPARATED AS ORIGINALLY REPORTED; HOWEVER, THE DEVICE WAS UNABLE TO BE FLUSHED. A WIRE GUIDE WAS UNABLE TO ADVANCE PAST THE HUB OF THE DEVICE. ADDITIONAL TESTING WAS PERFORMED, USING UNDERWATER ULTRASOUND, AT WHICH POINT A WIRE WAS ABLE TO BE PASSED THROUGH FROM THE HUB TO THE DISTAL TIP OF THE CATHETER, DISLODGING GREEN MATERIAL. THE DEVICE WAS THEN ABLE TO BE FLUSHED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. ONE RELEVANT NON-CONFORMANCE WAS NOTED ON A SUBASSEMBLY LOT; HOWEVER, ALL AFFECTED PRODUCT WAS SCRAPPED, AND 100% INSPECTIONS ARE IN PLACE TO IDENTIFY THE NON-CONFORMANCE. THE PRODUCT IFU STATES, ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, IFU, AND INVESTIGATION OF THE RETURNED DEVICE SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION; HOWEVER, AS THERE HAVE BEEN NO ADDITIONAL COMPLAINTS FROM THE FIELD, ALL NON-CONFORMING PRODUCT WAS SCRAPPED, AND 100% INSPECTIONS ARE IN PLACE, THERE IS NO EVIDENCE OF ADDITIONAL NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A MANUFACTURING/QUALITY CONTROL DEFICIENCY CONTRIBUTED TO THIS EVENT. DEFECT AWARENESS TRAINING HAS BEEN COMPLETED BY THE RESPONSIBLE PERSONNEL. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION: D4, D9, D10, G4, H3 H3: DEVICE EVALUATED BY MFG = OTHER (81) - DEVICE EVALUATION HAS BEGUN; HOWEVER, A CONCLUSION IS NOT YET AVAILABLE. 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 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.
AS REPORTED, DURING AN UNKNOWN PROCEDURE, A CXI SUPPORT CATHETER SEPARATED PRIOR TO USE. THE USER ATTEMPTED TO FLUSH THE DEVICE, HOWEVER, THE CATHETER WOULD NOT FLUSH. THE USER ADVANCED A WIRE TO CLEAR THE DEVICE, AND A RESIDUE REPORTEDLY CAME OUT OF THE CATHETER, WHICH THEN SEPARATED. ANOTHER CXI OF THE SAME TYPE WAS USED TO FINISH THE PROCEDURE, WITH NO FURTHER COMPLICATIONS. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
INFORMATION WAS AVAILABLE AND INADVERTENTLY OMITTED FROM THE PREVIOUS REPORT. UPON RETURN AND EVALUATION OF THE DEVICE, THE CATHETER WAS NOT SEPARATED AS ORIGINALLY REPORTED.
NO INFORMATION REGARDING THE PATIENT OR EVENT HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1345964 | CXI SUPPORT CATHETER | KRA CATHETER, CONTINUOUS FLUSH | KRA | COOK INC | G18373 | 14261189 | 00827002183735 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | ABBOTT COMMAND .014X300CM |