N
Patient 1
SUBMIT DATE:04/08/2016. AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.
MAUDE MDR 5563560
- MDR report key
- 5563560
- Report number
- 1018120-2016-00057
- Event key
- 0
- Event type
- 3
- Date received
- 2016-04-08
- 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 | 2016-04-08 | 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 REPORTED: THEY RECEIVED SHORTED PACKS OF COMP# (B)(4). TWO KITS HAD PACKS OF 9EA OF THIS GAUZE, INSTEAD OF THE 10 EA THAT SHOULD BE IN EACH PK. THIS WAS REPORTED ON THE PLASTIC MINOR PACK. NEITHER PATIENT INJURY NOR MEDICAL INTERVENTION HAS BEEN REPORTED.
N
Patient 1
THE DEVICE HISTORY RECORD (DHR) FOR LOT 15J196862X INDICATES THAT THERE WERE NO DEFECTS FOUND IN (B)(4) SAMPLES PER MACHINE INSPECTED FROM THE LOT. THERE WERE NO SAMPLES SUBMITTED WITH THIS COMPLAINT THEREFORE THE REPORTED CONDITION COULD NOT BE CONFIRMED. THE COMPLAINT SHALL BE REOPENED IF A SAMPLE IS RECEIVED. A POSSIBLE ROOT CAUSE MAY BE ATTRIBUTED TO THE SCALE CHALLENGE FOR WEIGHT COUNT IF IT WAS NOT SET UP CORRECTLY ON AUTOBANDERS, ADDED VARIABLES COULD HAVE CONTRIBUTED TO A WEIGHT DISCREPANCY FOR THE SCALE ON THE AUTOBANDERS. PRODUCT ORIGINATES FROM THE MANUFACTURING FACILITY AND THEN GOES TO ANOTHER SOURCE TO BE USED SUCH AS A KIT PACKING FACILITY. IT IS ALSO POSSIBLE THAT SPONGES COULD HAVE BEEN LOST DURING THAT PROCESS. 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. COUNTS ARE PERFORMED AS PART OF THE INSPECTION CRITERIA FOR IN PROCESS. THIS EVALUATION IS PERFORMED AT A TIGHTENED SAMPLE SIZE FOR MISCOUNTS. THE LOT MET ALL DEFINED ACCEPTANCE REQUIREMENTS AND WAS RELEASED. A FORMAL CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS INITIATED TO ADDRESS THE MISCOUNT COMPLAINTS FOR VISTEC PRODUCTS. DURING THIS CAPA, THE OFF LINE BANDING EQUIPMENT WAS DISCONTINUED. A REVERSAL OF THE AUTOBANDER TRAYS WAS PERFORMED TO TIGHTEN THE BANDS. AN ADDITIONAL CAPA HAS BEEN OPENED TO OPTIMIZE THE AUTOBANDER PROCESS IN WHICH THE PRODUCT SPECIFICATION HAS BEEN UPDATED TO INCLUDE THIS COMPLAINT TYPE AND IDENTIFY THE OCCURRENCE. A ROTATION OF STACKED SPONGES WILL BE REMOVED FROM THE PROCESS AND VALIDATION ACTIVITIES WILL BE PERFORMED. THIS CAPA IS CURRENTLY IN THE IMPLEMENTATION STAGE. 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. FINISHED GOODS TESTING IS CURRENTLY BEING PERFORMED AT A HEIGHTEN LEVEL FOR PRODUCTS PACKAGED USING BANDED 10 UNITS FOR MISCOUNT. THIS HEIGHTENED TESTING IS PERFORMED TO ENSURE CONTAINMENT FOR THE REPORTED CONDITION. SAMPLE AVAILABILITY WAS REQUESTED ON (B)(6). ON (B)(6), IT WAS CONFIRMED THAT SAMPLE IS NOT AVAILABLE BECAUSE THE CUSTOMER DISCARDED THE SAMPLE.