N
Patient 1
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
MAUDE MDR 6477488
- MDR report key
- 6477488
- Report number
- 2523190-2017-00046
- Event key
- 0
- Event type
- 3
- Date received
- 2017-04-10
- 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
- USER SANDRA LEE
- Address
- 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US
- Phone
- 609-609-6099
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FEMALE CATHETR 5-3/4 14FR | M18 - UROLOGY | INTEGRA - MILTEX | FBX | 29-32-14 | UNKNOWN | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-04-10 | 0 | 1. O |
Event Narratives#
D
Patient 1
DEALER INITIALLY REPORTS STRIPPING OF FLESH. ON 4/3/2017 PATIENT REPORTS "THE NEW (URETHRAL) CATHETERS WERE MANUFACTURED DIFFERENTLY & HAVE SHARP EDGES WHICH HAS TAKEN SMALL PIECES OF FLESH AFTER MY BLADDER HAS BEEN EMPTY UPON REMOVAL."
N
Patient 1
ON 04/10/2017 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - PICTURES PROVIDED BY THE CUSTOMER, STATING THAT THE CATHETERS ARE SHARP AND ARE STRIPPING OFF FLESH. UPON FURTHER INVESTIGATION, A 1.5AQL WAS PERFORMED ON EXISTING INVENTORY; IT IS FOUND THAT NONE OF THE CATHETERS HAVE SHARP EDGES. ACCORDING TO THE ATTACHED PICTURES PROVIDED BY THE END USER, WE ARE UNABLE TO DETECT PRODUCT MARKINGS AND PRODUCT ID; THEREFORE THE COMPLAINT IS UNCONFIRMED. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: NONE. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY/CORRECTIONS: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THERE WERE PICTURES OF THE NON-CONFORMING CATHETERS PROVIDED BY THE END USER AND THE COMPLAINT REPORT STATING THAT THEY ARE STRIPPING OFF FLESH. ACCORDING TO THE ATTACHED PICTURES PROVIDED BY THE END USER, WE ARE UNABLE TO DETECT PRODUCT MARKINGS AND PRODUCT ID; THEREFORE THE COMPLAINT IS UNCONFIRMED.
N
Patient 1
ON 5/31/2017 INTEGRA INVESTIGATION COMPLETED. DEVICE HISTORY EVALUATION - THERE WERE NINE FEMALE CATHETER RETURNED 4 OUT OF THE NINE WAS DAMAGED/SHARPED. THE COMPLAINT REPORT HAS BEEN CONFIRMED; THE ROOT CAUSE HAS BEEN IDENTIFIED AS A WORKMANSHIP OR MATERIAL DEFICIENCY. APPROPRIATE ACTION HAS BEEN IMPLEMENTED TO RECTIFY THIS MANUFACTURING DEFICIENCY.