FDA.reportPublic FDA data

MAUDE MDR 5672673

MDR report key
5672673
Report number
1820334-2016-00371
Event key
0
Event type
3
Date of event
2016-03-22
Date received
2016-05-23
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
MRS. RITA HARDEN
Address
750 DANIELS WAY BLOOMINGTON IN 47404 US
Phone
812-812-8123
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CHAIT PERCUTANEOUS CECOSTOMY CATHETEREXD IRRIGATOR, OSTOMYCOOK INCEXDN/ATDCS-100Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-05-2301. R

Event Narratives#

N

Patient 1

(B)(4). INVESTIGATION / EVALUATION: DURING THE COURSE OF INVESTIGATION, A REVIEW OF THE COMPLAINT HISTORY, DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL (QC), SPECIFICATIONS, TRENDS AND A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. THE VISUAL EXAMINATION DETERMINED THE TRAPDOOR FITTING WAS CLEANLY SEPARATED FROM THE CATHETER SHAFT. THE SHAFT OUTSIDE DIAMETER AND OPENING IN THE TRAPDOOR FITTING WERE MANUFACTURED TO SPECIFICATIONS. THERE WAS NO EVIDENCE OF TEARING OR BREAKAGE OF THE MATERIAL ON EITHER THE FITTING OR THE SHAFT. THE PRODUCT LOT NUMBER IS UNKNOWN. THEREFORE, A SEARCH OF PRODUCTION CONDITIONS AND NONCONFORMANCE DATA FROM BOTH MANUFACTURING AND RAW MATERIAL SUPPLIER CANNOT BE CONDUCTED. PER QUALITY CONTROL SPECIFICATION, THERE IS A CONFIRMATION OF THE CORRECT TYPE AND SIZE OF CATHETER TUBING AND A 100% CONFIRMATION THAT THE FITTING IS SECURELY ATTACHED TO THE CATHETER. THERE IS ALSO A VERIFICATION AND CONFIRMATION OF THE PRESENCE AND SECURITY OF THE PLUG IN THE TRAP DOOR FITTING AND AN OVERALL INSPECTION THAT THE SURFACE IS FREE OF EXCESSIVE DENTS, BUMPS, AND DEBRIS. AN INSTRUCTIONS FOR USE (IFU) IS PROVIDED THAT DESCRIBES THE PROPER CATHETER PLACEMENT, USAGE, AND MAINTENANCE TECHNIQUES, AS WELL AS APPROPRIATE WARNINGS AND PRECAUTIONS. A PATIENT GUIDE IS ALSO PROVIDED; WHICH INCLUDES SECTIONS ON PROPER USAGE, MAINTENANCE AND TROUBLESHOOTING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. WE WILL NOTIFY THE APPROPRIATE PERSONNEL AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE CONCLUSION OF THE QUALITY ENGINEERING RISK ASSESSMENT, FURTHER RISK REDUCTION IS NOT REQUIRED.

D

Patient 1

THE INITIAL REPORT PROVIDED ON 22MARCH2016 STATED THAT THE CHAIT TRAPDOOR BROKE OFF AT THE HUB AND THE PIGTAIL WAS RETRIEVED BY THE MOTHER OF THE PATIENT. A NEW CHAIT WAS PLACED SUCCESSFULLY. ADDITIONAL INFORMATION AND CLARIFICATION WAS REQUESTED AND ON 31MARCH2016 THE MANUFACTURER WAS INFORMED THAT THE TRAPDOOR BROKE OFF DUE TO ALL THE TURNING OF THE PATIENT. ADDITIONAL INFORMATION PROVIDED ON 10MAY2016 STATED THAT THE PRODUCT WOULD BE RETURNED FOR AN EVALUATION. THE COMPLAINT DEVICE WAS RECEIVED ON 17MAY2016. ON 11MAY2016 THE MANUFACTURER WAS ADVISED THAT THE MOTHER OF THE PATIENT RETRIEVED THE CATHETER-PIGTAIL FROM THE PATIENT VIA TWEEZERS. WE WERE FURTHER ADVISED ON 18MAY2016 THAT THE PATIENT WAS TAKEN TO THE HOSPITAL AND THE DEVICE WAS REPLACED BY THE CHILDREN'S SURGEON. A REVIEW OF THE ADDITIONAL INFORMATION/CLARIFICATION AND THE SUBSEQUENT EXAMINATION OF THE RETURNED DEVICE DETERMINED THE REPORTABILITY OF THIS EVENT.