N
Patient 1
AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.
MAUDE MDR 5584867
- MDR report key
- 5584867
- Report number
- 1018120-2016-00060
- Event key
- 0
- Event type
- 3
- Date received
- 2016-04-18
- 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 | 2016-04-18 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT THE CUSTOMER HAD AN ISSUE WITH A GAUZE SPONGE.THE CUSTOMER STATES THE GAUZE IS SHREDDING WHEN THE PACKAGE IS OPENED.
N
Patient 1
SUBMIT DATE: 09/21/2016. THE DEVICE HISTORY RECORD (DHR) FOR LOT 15L062862 INDICATES THAT NO ISSUES WERE FOUND IN SAMPLES INSPECTED FROM THE LOT. THERE WERE NO SAMPLES SUBMITTED WITH THIS COMPLAINT. THE REPORTED CONDITION COULD NOT BE CONFIRMED. THIS COMPLAINT SHALL BE REOPENED IF A SAMPLE IS RECEIVED. THE EXACT ROOT CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED WITHOUT AN ACTUAL SAMPLE TO EXAMINE HOWEVER, THE LINT/SHORT FIBERS WERE POSSIBLY CAUSED WITHIN THE SLITTING PROCESS IN WHICH THE VACUUM SUCTION WAS NOT STRONG ENOUGH TO REMOVE THE EXCESS FIBERS AFTER THE GAUZE WAS CUT INTO 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, 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 INVESTIGATION WAS OPENED BECAUSE OF LINTING/SHORT FIBERS AND IS CURRENTLY IN OPEN INVESTIGATION. 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.