FDA.reportPublic FDA data

MAUDE MDR 6753176

MDR report key
6753176
Report number
1320894-2017-00176
Event key
0
Event type
3
Date received
2017-07-30
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
MS. LINDSEY SHEPPARD
Address
525 FRENCH ROAD UTICA NY 13502 US
Phone
727-727-7273
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1POOLE SUCTION INSTRUMENT 50/CSURGICAL INSTRUMENTS, STERILECONMED CORPORATIONBYY0035040201610031Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-300

Event Narratives#

N

Patient 1

THE REPORTED POOLE SUCTION INSTRUMENT WAS RETURNED IN ITS ORIGINAL UNOPENED PACKAGING TO CONMED FOR EVALUATION OF "DEFECTIVE SEAL". LABEL VERIFICATION WAS PERFORMED. VISUAL INSPECTION BY THE PACKAGING ENGINEER CONFIRMED A BREACH OF STERILITY. FURTHER INSPECTION OF THE DEVICE DETERMINED THE DEVICE WAS IN THE SEAL AREA DURING THE SEALING PROCESS IN THE FORM FILL/SEAL MACHINE. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT. THE PRODUCTS RELEASED FOR DISTRIBUTION WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. OF THE LOT CONTAINING (B)(4) UNITS, ONE ADDITIONAL COMPLAINT HAS BEEN FILED FOR THIS FAILURE. A REVIEW OF COMPLAINT HISTORY REVEALED 15 COMPLAINTS HAVE BEEN REPORTED IN THE PAST TWO YEARS. (B)(4). THIS REPORTED PACKAGING ISSUE WAS OBVIOUS TO THE DISTRIBUTOR, PROMPTING THE RETURN OF THE DEVICE FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT. CLINICAL PRACTICE WOULD INCLUDE EXAMINATION AND VERIFICATION OF THE PRODUCT AND ITS ORIGINAL PACKAGING TO ENSURE BOTH ARE INTACT. THIS PACKAGE WAS NOT SEALED AND THEREFORE WOULD PROMPT THE END USER TO DISCARD IT AND OBTAIN A NEW STERILE DEVICE. TO DATE THERE HAVE BEEN NO REPORTED LONG TERM ADVERSE EFFECTS RELATED TO THIS ISSUE, HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO PREVENT FURTHER OCCURRENCES.

D

Patient 1

THE DISTRIBUTOR IN (B)(4) REPORTED A DEFECTIVE SEAL ON ITEM 0035040- POOLE SUCTION INSTRUMENT. IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION PRIOR TO DISTRIBUTION TO AN END-USER. THIS REPORT IS RAISED ON THE BASIS OF A MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.