N
Patient 1
SUBMIT DATE: 2017/JUNE/12. AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.
MAUDE MDR 6633276
- MDR report key
- 6633276
- Report number
- 3009211636-2017-05164
- Event key
- 0
- Event type
- 3
- Date received
- 2017-06-12
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- EDWARD ALMEIDA
- Address
- 15 HAMPSHIRE ST. MANSFIELD MA 02048 US
- Phone
- 508-508-5084
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PALINDROME | CATHETER, HEMODIALYSIS, IMPLANTED, COATED | COVIDIEN MANUF. SOLUTIONS SA | NYU | 8888145044P | 8888145044P | 1520400091 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-06-12 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2017 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THERE IS A LEAK IN THE CATHETER UNDER THE LUER CONNECTOR.
N
Patient 1
THIS COMPLAINT HAS NOT BEEN CONFIRMED. THE ACTUAL SAMPLE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATIONS. NO ADDITIONAL INFORMATION, PICTURES OR VIDEOS WERE RECEIVED. SINCE NO SAMPLE WAS RETURNED FOR EXAMINATION, IT WAS NOT POSSIBLE TO EVALUATE IT AS PART OF A COMPREHENSIVE FAILURE INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW REVEALED NO DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO A COMPLAINT OF THIS FAILURE MODE. ALL QUALITY ASSURANCE TESTING PERFORMED DURING MANUFACTURING WAS ACCEPTABLE. THE QUALITY ASSURANCE REVIEW OF THE VISUAL, PHYSICAL AND DIMENSIONAL EVALUATION RESULTS INDICATED THAT THE PRODUCT MET SPECIFICATION REQUIREMENTS. IN ADDITION, ALL DHRS ARE REVIEWED FOR ACCURACY PRIOR TO PRODUCT RELEASE. NO ADDITIONAL INFORMATION WAS RECEIVED FOR INVESTIGATION. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED FOR FURTHER INVESTIGATION. THE AVAILABLE INFORMATION WAS ANALYZED AND IT DID NOT ALLOW CONFIRMING A ROOT CAUSE FOR THE EVENT, HOWEVER, PROCESS AND DESIGN FAILURE MODE AND EFFECTS ANALYSIS ( PFMEA AND DFMEA) WERE REVIEWED IN ORDER TO IDENTIFY THE POSSIBLE CAUSES FOR THE FAILURE. THE POTENTIAL CAUSES WERE IDENTIFI ED AS: DEFECTIVE MATERIAL, OPERATOR FAILED TO FOLLOW PROCESS AND INSPECTION PROCEDURES, CUSTOMER MISUSE, OR EQUIPMENT MALFUNCTION. NO TRENDS OR TRIGGERS HAVE BEEN FOUND, THEREFORE, A CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS NOT DEEMED NECESSARY AT THIS TIME. 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.
D
Patient 1
THE CUSTOMER STATES THERE IS A LEAK IN THE CATHETER UNDER THE LUER CONNECTOR.