ULTRATHANE COPE NEPHROURETEROSTOMY SET

Report

Report Number: 1820334-2022-00285
Event Type: Injury
Date Received: February 22, 2022
Date of Event: February 14, 2022
Report Date: November 7, 2022
Manufacturer: COOK INC
Product Code: FAD
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. PMA/510(K) #: K171603. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

Additional Manufacturer Narrative · 0

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. PMA/510(K) #: K171603. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

Additional Manufacturer Narrative · 0

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.

Additional Manufacturer Narrative · 0

INVESTIGATION ¿ EVALUATION: IT WAS REPORTED BY (B)(6) HOSPITAL, THAT THE CATHETER IN AN ULTRATHANE COPE NEPHROURETEROSTOMY SET (RPN: ULT8.5-8.5-24-NUCL-B-RH; LOT# UNKNOWN), LEAKED AFTER 24 HOURS. THE PATIENT THEN RETURNED TO THE USER FACILITY AND THE DEVICE WAS REPLACED. NO OTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. REVIEWS OF DOCUMENTATION INCLUDING THE QUALITY CONTROL, SPECIFICATIONS, AND INSTRUCTIONS FOR USE (IFU), OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE COMPLETED. 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 PREVENT THE RELEASE OF NONCONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER FOR THIS DEVICE. THEREFORE, COOK MEDICAL PERFORMED AN EXPANDED SALES SEARCH FOR THE REPORTED DEVICE, ULT8.5-8.5-24-NUCL-B-RH, ULTRATHANE COPE NEPHROURETEROSTOMY SET, SHIPPED TO THIS CUSTOMER BETWEEN 14FEB2018 AND 14FEB2022. A REVIEW OF SALES RECORDS WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. AS A RESULT, COOK MEDICAL INC. WAS UNABLE TO REVIEW THE DEVICE HISTORY RECORD (DHR). COOK ALSO REVIEWED PRODUCT LABELING. THIS DEVICE IS SUPPLIED WITH AN INSTRUCTION'S FOR USE BOOKLET, (T_NUCL_REV5) PROVIDING STEP BY STEP INSTRUCTIONS FOR USE, IN ADDITION TO ADVISING THE USER PROPER STORAGE CONDITIONS. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR AND IFU SUGGESTS THAT THE DEVICE WAS NOT MANUFACTURED OUT OF SPECIFICATION, AND THAT THERE ARE NO NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD A CAPA INVESTIGATION WAS PREVIOUSLY OPENED FOR THIS PRODUCT ISSUE. THE CAPA INVESTIGATION IMPLEMENTED CORRECTIVE ACTIONS RELATED TO MANUFACTURING AND QUALITY CONTROL. AS THE LOT NUMBER IS UNKNOWN, IT IS UNKNOWN WHETHER THE COMPLAINT DEVICE UNDERWENT THESE CORRECTIONS. THEREFORE, IT IS POSSIBLE THAT A MANUFACTURING OR QUALITY CONTROL DEFICIENCY CONTRIBUTED TO THIS INCIDENT AS DETERMINED FROM THE CAPA INVESTIGATION. COOK NOTIFIED THE APPROPRIATE PERSONNEL. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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.

Additional Manufacturer Narrative · 0

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. CORRECTION: D9, H3 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.