N
Patient 1
(B)(4). THIS REPORT IS FOR THE FIRST IN A SERIES OF TWO CONSECUTIVE PRODUCT PROBLEMS WITH THE SAME PATIENT. THE SECOND ISSUE HAS BEEN REPORTED UNDER MDR # 1036844-2016-00559.
MAUDE MDR 6081646
- MDR report key
- 6081646
- Report number
- 1036844-2016-00558
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-10-10
- Date received
- 2016-11-07
- 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
- JAMIE HARTZ
- Address
- 2400 BERNVILLE ROAD READING PA 19605 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CANNON II PLUS REPLACEMENT HUB SET | CHRONIC HEMODIALYSIS PRODUCTS | ARROW INTERNATIONAL INC. | NFK | CAR-02400 | 23F14F1348 | R | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-11-07 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT IN NEPHROLOGY, THE USER SUCCESSFULLY INSERTED A CHRONIC HEMODIALYSIS CATHETER INTO THE PATIENT'S JUGULAR. AFTER SIX MONTHS IN USE, THE NURSE FOUND LEAKAGE WHEN THE PATIENT HAD HEMODIALYSIS TREATMENT. AS A RESULT, NEW EXTENSION TUBE WAS REPLACED, HOWEVER, AFTER TWO HEMODIALYSIS TREATMENTS, THE EXTENSION TUBE CRACKED AGAIN. DOCTOR REPLACED ANOTHER NEW EXTENSION TUBE. A DELAY WAS REPORTED, HOWEVER, THERE WAS NO ADDITIONAL HARM TO THE PATIENT DUE TO THIS DELAY OR AS A RESULT OF THIS OCCURRENCE. THE PATIENT INVOLVED WAS A (B)(6) MALE, (B)(6) TALL, WEIGHING (B)(6).
N
Patient 1
QN#(B)(4). DEVICE EVALUATION: COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED BECAUSE NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND IT DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. THE PROBABLE CAUSE OF A LEAK IN THE CONNECTOR ASSEMBLY COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE. NO FURTHER ACTION WILL BE TAKEN.
N
Patient 1
(B)(4). DEVICE EVALUATION: THE REPORT OF A LEAK IN THE CONNECTOR ASSEMBLY COULD NOT BE DIRECTLY CONFIRMED. RETURNED ON THIS COMPLAINT WAS A BLUE LUER HUB. THE EXTENSION LINE WAS CUT OFF AT THE ENTRANCE TO THE HUB. THE REMAINDER OF THE CONNECTOR ASSEMBLY WAS NOT RETURNED. THE LUER HUB WAS EXAMINED MICROSCOPICALLY. THERE WAS ONE CRACK IN THE HUB RUNNING FROM THE ENTRANCE OF THE HUB AND DOWN THE SIDE. FUNCTIONAL TESTING WAS PERFORMED ON THE HUB BY ATTACHING IT TO THE LAB LEAK TESTER. THE OTHER END OF THE HUB WAS OCCLUDED. THE LEAK TESTER WAS TURNED ON AND THE PRESSURE WAS INCREASED TO 45 PSI (300KPA) FOR 30 SECS. NO LEAK WAS OBSERVED IN THE HUB. THE LUER HUB WAS THEN TESTED WITH WATER AND A 10 ML LUER SLIP SYRINGE WITH THE OTHER END OF THE HUB OCCLUDED. NO LEAK WAS OBSERVED IN THE HUB. THE IFU PROVIDED WITH THE SET WARNS THAT REPEATED OVER TIGHTENING OF BLOODLINES, SYRINGES, AND CAPS WILL REDUCE CONNECTOR LIFE AND COULD LEAD TO POTENTIAL CONNECTOR FAILURE. IT ALSO STATES TO AVOID EXCESSIVE OR PROLONGED USE OF ALCOHOL BASED SOLUTIONS AND OINTMENTS TO CLEAN THE CATHETER AND THAT SOLUTION SHOULD BE COMPLETELY DRY BEFORE APPLYING AN OCCLUSIVE DRESSING. IT ALSO STATES NOT TO USE ACE TONE WITH THIS CATHETER AND THAT THE CATHETER, EXTENSION LINES AND CONNECTORS SHOULD BE EXAMINED BEFORE AND AFTER EACH USE. OTHER REMARKS: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. BASED ON THE CONDITION OF THE SAMPLE AND THE REPORT THAT THE LEAK OCCURRED WHILE IT WAS IN USE, OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS COMPLAINT. NO FURTHER ACTION WILL BE TAKEN.