N
Patient 1
(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.
MAUDE MDR 5952181
- MDR report key
- 5952181
- Report number
- 1820334-2016-00975
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-08-19
- Date received
- 2016-09-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. LARRY POOL
- Address
- 750 DANIELS WAY BLOOMINGTON IN 47404 US
- Phone
- 812-812-8123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-09-15 | 0 | 1. O |
Event Narratives#
D
Patient 1
A MALE PATIENT WAS REPORTEDLY HAVING NEPHROSTOMY CATHETER REPLACEMENTS APPROXIMATELY EVERY 3 WEEKS, ON (B)(6) 2016 THE CATHETER WAS REPLACED AT THE HOSPITAL. THE PATIENT LEFT THE HOSPITAL AFTER RECEIVING DRIP INFUSION FOR AN UNKNOWN REASON, ONCE HOME HE DISCOVERED THE CATHETER WAS LEAKING URINE. THE HOSPITAL NOTED A LOOSE CONNECTOR WAS CAUSING THE LEAKAGE BUT THEY WERE UNABLE TO TIGHTENED THE CONNECTION. THE PATIENT RETURNED TO THE HOSPITAL BUT A UROLOGICAL PHYSICIAN WAS UNAVAILABLE, HE WAS SENT TO A NEARBY HOSPITAL WHERE THE CATHETER WAS REPLACED. REPORTEDLY THE PATIENT DEVELOPED A FEVER FROM PYELONEPHRITIS AFTER PLACEMENT OF THE NEW CATHETER, IT IS UNKNOWN WHAT CAUSED THE INFECTION OR IF IT WAS RELATED TO URINE LEAKAGE AND /OR CATHETER REPLACEMENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
N
Patient 1
(B)(4). PRODUCT HAS NOT BEEN RECEIVED AND THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.
D
Patient 1
A MALE PATIENT WAS REPORTEDLY HAVING NEPHROSTOMY CATHETER REPLACEMENTS APPROXIMATELY EVERY 3 WEEKS, ON (B)(6) 2016 THE CATHETER WAS REPLACED AT THE HOSPITAL. THE PATIENT LEFT THE HOSPITAL AFTER RECEIVING DRIP INFUSION FOR AN UNKNOWN REASON, ONCE HOME HE DISCOVERED THE CATHETER WAS LEAKING URINE. THE HOSPITAL NOTED A LOOSE CONNECTOR WAS CAUSING THE LEAKAGE BUT THEY WERE UNABLE TO TIGHTENED THE CONNECTION. THE PATIENT RETURNED TO THE HOSPITAL BUT A UROLOGICAL PHYSICIAN WAS UNAVAILABLE, HE WAS SENT TO A NEARBY HOSPITAL WHERE THE CATHETER WAS REPLACED. REPORTEDLY THE PATIENT DEVELOPED A FEVER FROM PYELONEPHRITIS AFTER PLACEMENT OF THE NEW CATHETER, IT IS UNKNOWN WHAT CAUSED THE INFECTION OR IF IT WAS RELATED TO URINE LEAKAGE AND /OR CATHETER REPLACEMENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
N
Patient 1
(B)(4). A REVIEW OF THE COMPLAINT HISTORY, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE NO PHYSICAL EXAMINATION COULD BE PERFORMED. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.