N
Patient 1
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
MAUDE MDR 5983343
- MDR report key
- 5983343
- Report number
- 1018120-2016-00144
- Event key
- 0
- Event type
- 3
- Date received
- 2016-09-28
- 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
- EDWARD ALMEIDA
- Address
- 15 HAMPSHIRE STREET MANSFIELD MA 02048 US
- Phone
- 508-508-5084
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-09-28 | 0 |
Event Narratives#
D
Patient 1
THE PLANT DETERMINED DURING THE SAMPLE ANALYSIS THAT THE PRODUCT WAS LINTING WHILE SHAKING THE GAUZE DURING THE INVESTIGATION THAT WAS COMPLETED ON (B)(6) 2016 THEREFORE THIS EVENT BECOMES REPORTABLE.
N
Patient 1
THE DEVICE HISTORY RECORD (DHR) FOR LOT 15K124762 INDICATES THAT THERE WERE NO DEFECTS DETECTED IN THE 80 SAMPLES INSPECTED THAT WENT INTO THIS LOT. A BUNDLE OF VISTEC ELEMENT SPONGES WITH EMBOSSING IDENTIFICATION D AND PACKAGE LIDDING WAS SENT FOR EVALUATION. A VISUAL EXAMINATION DID NOT SHOW ANY NOTICEABLE FIBERS; HOWEVER, WHEN THE GAUZE BUNDLES WERE SLIGHTLY SHAKEN THE SHORT FIBERS FELL FROM THE SPONGE. THE REPORTED CONDITION IS CONFIRMED. THE ROOT CAUSE FOR THE LINTING IS THAT WHEN THE GAUZE IS SLIT INTO ASSIGNED WIDTHS USING THE PICKNEY BLADES SHORT FIBERS ARE CREATED. A VACUUM SYSTEM CONNECTED TO THE SLITTING PROCESS SHOULD PULL THE FIBERS FROM THE SLITS. PRIOR TO A LOT'S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. SPECIFICALLY, A VISUAL INSPECTION FOR CONTAMINATION IS PERFORMED DURING EACH INSPECTION. THE LOT MET ALL DEFINED ACCEPTANCE REQUIREMENTS AND WAS RELEASED. A FORMAL CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS OPENED TO ADDRESS THE ISSUE OFF LINTING AND SHORT FIBERS AND IS CURRENTLY IN OPEN INVESTIGATION PHASE. THE CORRECTIVE ACTION PLAN FOR THIS CAPA IS TO: DEVELOP A PROCESS TO MEASURE THE AMOUNT OF SHORT FIBERS PER SPONGE. INSTALL A SYSTEM TO SIGNIFY IF THE VACUUM IS WORKING ON THE TENTER AND IS AT THE ON POSITION. INCREASE THE AMOUNT OF SUCTION ON THE TENTER VACUUMS. CREATE A SYSTEM TO MAKE SURE ALL KNIFE ASSEMBLIES IN PROCESS DESCRIBED ARE ALIGNED PROPERLY BEFORE THE CUTTING PROCESS. THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES TO DETERMINE THE NEED FOR ADDITIONAL CORRECTIVE ACTIONS. THE PRODUCTION DEPARTMENT WILL BE NOTIFIED OF THIS INCIDENT WITH A COPY OF THIS COMPLAINT RESPONSE.