MAHURKAR
Received Jun 9, 2017 · Event occurred May 4, 2017
Report 3009211636-2017-05161 · MDR key 6629686
Device
Generic name
Catheter, Hemodialysis, Triple Lumen, Implanted
Manufacturer
Covidien Mfg Solutions S.a.Model number
UNK DYCatalog number
UNK DY
Lot number
15174200076
Product problems
- Detachment Of Device Component
- Detachment Of Device Component
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE PRODUCT CODE RELATED TO THIS COMPLAINT IS UNKNOWN. THE PROVIDED LOT NUMBER DOES NOT EXIST IN THE MANUFACTURING PLANTS RECORDS. BECAUSE A VALID LOT NUMBER WAS NOT PROVIDED, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED. THE PHYSICAL SAMPLE INVOLVED WAS NOT RETURNED FOR EVALUATION. THREE PHOTOS WERE PROVIDED BY THE CUSTOMER. VISUAL EVALUATION OF THESE PHOTOS WAS PERFORMED. A CATHETER INSIDE THE ORIGINAL BAG WAS OBSERVED IN THE PHOTOS. THE CATHETER PRESENTED SIGNS OF USE. VISUAL INSPECTION OF THIS CATHETER REVEALED THAT THE INFUSION LUMEN (MIDDLE LUMEN) WAS COMPLETELY SEPARATED FROM THE ADAPTER INFUSION. AN ISHIKAWA DIAGRAM WAS USED TO DETERMINE THE POTENTIAL CAUSES FOR THIS EVENT. THE REPORTED CONDITION HAS BEEN CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE CAN BE CONSIDERED AS MISUSE; THE REPORTED CONDITION WAS MOST LIKELY DAMAGE CAUSED DUE TO AN INAPPROPRIATE MANIPULATION BY THE USER. NO COMPLAINT TRIGGERS OR TRENDS WERE IDENTIFIED AND NO HARM WAS REPORT IN THIS COMPLAINT. NO CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) ARE REQUIRED. IT MUST BE NOTED THAT IN-PROCESS CONTROLS, SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING, ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
THE CUSTOMER STATES DURING USE OF THE TRIPLE LUMEN CATHETER THE PIGTAIL BROKE OFF THE TOP OF THE EXTENSION TUBE WHILE THE STAFF WAS ATTACHING TUBING TO IT. THE CATHETER WAS REMOVED AND TREATMENT WAS DISCONTINUED.
Additional Manufacturer Narrative
SUBMIT DATE: 2017/JUNE/09. AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2017 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES DURING USE OF THE TRIPLE LUMEN CATHETER THE PIGTAIL BROKE OFF THE TOP OF THE EXTENSION TUBE WHILE THE STAFF WAS ATTACHING TUBING TO IT. THE CATHETER WAS REMOVED AND TREATMENT WAS DISCONTINUED.