SHEATH, PERITONEAL INTRODUCER, 46CM - BOX OF 5

Additional Manufacturer Narrative

REFERENCE TO COMPLAINT# (B)(4). INVESTIGATION AND FINDINGS: CAPA TRENDING REVIEW: THERE ARE NO CAPA'S RELATED TO THIS ISSUE AND THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. RISK MANAGEMENT FILE REVIEW: PER MDHA-SSS_SH-001 REV01, HAZARD ID IIU-008A, COMPLICATIONS WITH CATHETER IMPLANTATION PROCEDURE, MODERATE RISK. SERVICE RECORD REVIEW: SERVICE REPAIR INVESTIGATIONS WILL BE CONDUCTED DURING THE REPAIR PROCESS AND TREND DATA WILL BE REVIEWED. COMPLAINT TRENDING REVIEW: PER QMS-004442 COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED. COMPLAINT VERIFIED, RESOLVED ON-SITE AND NO FURTHER ACTION NECESSARY.

Description of Event or Problem

CUSTOMER'S PRODUCT WAS TOO STICKY AND COULD NOT BE FED THROUGH CAUSING DELAY IN SURGERY. CUSTOMER HAD TO ADJUST PRODUCT BY TYING THE CATHETER TO THE SHEATH. NO PATIENT INJURY OCCURRED.

Additional Manufacturer Narrative

CUSTOMER'S PRODUCT WAS TOO STICKY AND COULD NOT BE FED THROUGH CAUSING DELAY IN SURGERY. PRODUCT COULD BE STICKY IF NOT ENOUGH SALINE IS INTRODUCED TO THE CATHETER BEFORE INSERTING INTO THE TUBE.. NO PATIENT INJURY OCCURRED. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: PATIENT INFORMATION - NO PATIENT INJURY OCCURRED. RELEVANT TESTS / LABORATORY DATA - THIS SECTION IS NOT APPLICABLE, THIS INFORMATION WAS NOT PROVIDED. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: THIS SECTION IS NOT APPLICABLE, THIS INFORMATION WAS NOT PROVIDED. SERIAL - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE A SERIAL NUMBER. EXPIRATION DATE (DD-MMM-YYYY) REQUESTED FROM THE CUSTOMER BUT INFORMATION NOT PROVIDED. UNIQUE IDENTIFIER (UDI) # REQUESTED FROM THE CUSTOMER BUT INFORMATION NOT PROVIDED. IF IMPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. IF EXPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. REPROCESSOR NAME AND ADDRESS - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDING TREATMENT OF EVENT) - THIS SECTION IS NOT APPLICABLE TO THIS TYPE OF DEVICE. FOR USE BY USER FACILITY / IMPORTER - NOT APPLICABLE AS WE ARE NOT A FACILITY OR IMPORTER OF DEVICE. IF IND, GIVE PROTOCOL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. ADVERSE EVENT TERMS - THIS SECTION IS NOT APPLICABLE TO MEDICAL DEVICES. DEVICE MANUFACTURE DATE (DD-MMM-YYYY) NOT AVAILABLE AT THE TIME OF THIS REPORT. IF REMEDIAL ACTION INITIATED , CHECK TYPE - THIS SECTION IS NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED. IF ACTION REPORTED TO FDA UNDER 21 USC 360I (F), LIST CORRECTION / REMOVAL REPORTING NUMBER - THIS SECTION IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21USC 360I(F).

Description of Event or Problem

CUSTOMER'S PRODUCT WAS TOO STICKY AND COULD NOT BE FED THROUGH CAUSING DELAY IN SURGERY. CUSTOMER HAD TO ADJUST PRODUCT BY TYING THE CATHETER TO THE SHEATH. NO PATIENT INJURY OCCURRED.

Additional Manufacturer Narrative

REFERENCE TO COMPLAINT#: (B)(4) 26TH JUNE 2020. INVESTIGATION AND FINDINGS: ON 07-MAY-2020: DATABASE SIEBEL SHOWS CUSTOMER CONFIRMED THE PART IS NOT AVAILABLE FOR RETURN. CUSTOMER COMPLAINT FORM RETURNED AND CONFIRMED NO PATIENT INJURY, HOWEVER DELAY IN SURGERY AND CUSTOMER HAD TO ADJUST PRODUCT BY TYING THE CATHETER TO THE SHEATH. ON 15-MAY-2020: EMAIL COMMUNICATIONS WITH SALES AND CLINICAL REPS CONFIRMS PRODUCT COULD BE STICKY IF NOT ENOUGH SALINE IS INTRODUCED TO THE CATHETER BEFORE INSERTING INTO THE TUBE. ON 19-MAY-2020: ADDITIONAL FEEDBACK RECEIVED FROM R&D ENGINEERING, CONFIRMED STATEMENT ABOUT SILICONE NEEDED TO BE SOAKED BEFORE INSERTING INTO THE TUBE. ON 05-JUN-2020: REVIEW OF PRODUCT EVALUATION FORM SHOWS DHR WAS UNABLE TO BE REVIEWED AS SERIAL NUMBER WAS NOT PROVIDED. FOUND NO ASSOCIATED CAPAS. COMPLAINT HISTORY WAS REVIEWED FOR THE PREVIOUS TWO YEARS AND FOUND 0 SIMILAR COMPLAINTS, GIVING AN INCIDENT RATE OF 0%. REVIEW OF MEDICAL DEVICE HAZARD ANALYSIS SHOWS INCIDENT TO IDENTIFY AS A MODERATE RISK. DEPOT REPAIR COULD NOT CONFIRM FAILURE AS PRODUCT WAS NOT RETURNED. UDI NUMBER: (B)(4). MANUFACTURING DATE: INFORMATION NOT AVAILABLE.

Description of Event or Problem

CUSTOMER'S PRODUCT WAS TOO STICKY AND COULD NOT BE FED THROUGH CAUSING DELAY IN SURGERY. CUSTOMER HAD TO ADJUST PRODUCT BY TYING THE CATHETER TO THE SHEATH. NO PATIENT INJURY OCCURRED.