FDA.reportPublic FDA data

MAUDE MDR 8661006

MDR report key
8661006
Report number
2951238-2019-00898
Event key
0
Event type
3
Date received
2019-05-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. CONNIE TUBERA
Address
2400 RINGWOOD AVENUE SAN JOSE CA 95131 US
Phone
408-408-4089
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COLLECTION SET TUBING PVC (10/PK)COLLECTION SET TUBINGSEISA MEDICAL SALES, LLCHHI23116S189313Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-310

Event Narratives#

N

Patient 1

THE DEVICE WAS RETURNED FOR EVALUATION. THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) CONDUCTED AN INVESTIGATION FOR THE REPORTED DEVICE PACKAGING ISSUE. A VISUAL INSPECTION NOTED THE PACKAGE WAS COMPLETELY SEALED AND A SINGLE HAIR STRAND WAS FOUND INSIDE THE PACKAGING. IN ADDITION, THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) REVIEWED THE DEVICE HISTORY RECORDS (DHR) FOR THE SUBJECT DEVICE AND LOT NUMBER AND NO QUALITY ISSUES WERE NOTED DURING THE MANUFACTURING PROCESS. THE OEM ALSO REVIEWED THE PHOTO IMAGES OF THE RECEIVED PRODUCT AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT IS LIKELY DUE TO EMPLOYEES EXITING AND ENTERING THE GOWNING ROOM AT THE SAME TIME, RESULTING IN A HAIR FALLING OFF AN EMPLOYEE?S GOWN. THE OEM REPORTED THE GOWNING PROCEDURE WILL BE REVISED TO IMPLEMENT TURNING INSIDE OUT THE GOWN PRIOR TO PLACING IT ON THE HANGER WHEN LEAVING THE CLEAN ROOM, IN ORDER TO ELIMINATED THE POSSIBILITIES OF HAIR FALLING ONTO THE PRODUCT. IN ADDITION, RETRAIN ALL PERSONAL OF THE CLEAN ROOM REGARDING CLEANING/SANITIZATION, AND REVISING WORK INSTRUCTIONS TO INCLUDE IMPLEMENTATION OF AIR GUN TO PROPERLY CLEAN THE HOSE OF CONTAMINATION.

D

Patient 1

THE MANUFACTURER WAS INFORMED THAT DURING SETUP AND PRIOR TO OPENING THE DEVICE PACKAGING; THE USER FACILITY INSPECTED THE PACKAGE AND FOUND A HAIR INSIDE THE STERILE PACKAGING. THERE WAS NO PATIENT INJURY WAS REPORTED.