MAHURKAR
Received Apr 30, 2025 · Event occurred Jan 8, 2025
Report 1282497-2025-00283 · MDR key 21940178
Device
Generic name
Catheter, Hemodialysis, Non-implanted
Manufacturer
Covidien LlcModel number
8888135131Catalog number
8888135131
Lot number
2335200145
Product problems
- Break
- Insufficient Device Problem Information
- Break
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE SALES REPRESENTATIVE CONFIRMED THAT THE RETURNED SAMPLE HAD BEEN SENT BY MISTAKE, AND THERE WAS NO ISSUE TO REPORT. THERE WERE NO PROBLEMS OR COMPLAINTS ASSOCIATED WITH THE RETURNED SAMPLE, AS REPORTED BY THE CUSTOMER.
Additional Manufacturer Narrative
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Additional Manufacturer Narrative
D10 - CONCOMITANT PRODUCT: 8888145044 PALINDROME H 23/40 KT, 8888145044, LOT: 2326900100 8888135131 13.5FR 13.5CM MAHKA Q+ SEKIT, 8888135131, LOT: 2335200145. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Description of Event or Problem
ACCORDING TO THE REPORTER, AFTER ONE WEEK OF USAGE OF DIALYSIS, VENOUS (BLUE) END LUER ADAPTERS ON THREE CATHETERS WERE CRACKED AND HAD LEAKED BLOOD. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. NO CLEANING AGENT WAS USED ON THE DEVICE. THE CATHETER WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.