N
Patient 1
SUBMIT DATE: 07/28/2016. AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.
MAUDE MDR 5831484
- MDR report key
- 5831484
- Report number
- 1018120-2016-00106
- Event key
- 0
- Event type
- 3
- Date received
- 2016-07-28
- 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 | 2016-07-28 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A GAUZE SPONGE. THE CUSTOMER REPORTS X-RAY GAUZE LINTING.
N
Patient 1
THE FOLLOWING IS OFFERED IN RESPONSE TO YOUR RECENT COMPLAINT SUBMISSION: AN INVESTIGATION OF THE REPORTED CONDITION WAS PERFORMED AT THE MANUFACTURING FACILITY. THERE WAS NO LOT NUMBER PROVIDED WITH THIS COMPLAINT, THEREFORE IT WAS NOT POSSIBLE TO COMPLETE A REVIEW OF THE LOT HISTORY RECORD. THERE WERE (B)(4) BANDS OF (B)(4) VISTEC ELEMENT SPONGES RETURNED WITH THIS COMPLAINT. NO IDENTIFYING PACKAGING WAS SENT WITH THE SAMPLES. AN ACCEPTABLE QUALITY LEVEL (AQL) SAMPLE PER THE INSPECTION STANDARD REQUIRES A (B)(4) PIECE SAMPLE. THE SAMPLES RECEIVED DID NOT SHED FIBERS FROM THE SPONGES WHEN SHAKEN. BASED ON THE SAMPLES RECEIVED THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. 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 INSPECTIONS ARE CONDUCTED FOR CONTAMINATION DURING EACH INSPECTION. THE LOT MET ALL DEFINED ACCEPTANCE REQUIREMENTS AND WAS RELEASED. A FORMAL CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS OPENED TO ADDRESS LINTING/SHORT FIBERS AND IS CURRENTLY IN OPEN INVESTIGATION STAGE. 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 CONFIRM THE VACUUM ON THE TENTER IS TURNED ON AND OPERATING. INCREASE THE AMOUNT OF SUCTION ON THE TENTER VACUUMS. CREATE A SYSTEM TO MAKE SURE ALL KNIFE ASSEMBLIES ARE ALIGNED PROPERLY BEFORE THE CUTTING PROCESS. NO CONTAINMENT WAS PERFORMED TO FOR THE REPORTED CONDITION.