N
Patient 1
SUBMIT DATE: 08/23/2016. AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.
MAUDE MDR 5896425
- MDR report key
- 5896425
- Report number
- 1018120-2016-00114
- Event key
- 0
- Event type
- 3
- Date received
- 2016-08-23
- 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 | 2016-08-23 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A GAUZE PAD. CUSTOMER REPORTS: THERE WERE 11 INSTEAD OF 10 IN THE PACK. THIS WAS COUNTED IN THE O.R. AND NOTICED PRIOR TO USE.
N
Patient 1
SUBMIT DATE: 10/04/2016. THE DEVICE HISTORY RECORD (DHR) FOR LOT 16C119562 INDICATES THAT THERE WERE NO DEFECTS FOUND IN 80 SAMPLES PER MACHINE INSPECTED FROM THE LOT. ONE OPEN PACKAGE CONTAINING ELEVEN LOOSE UNBANDED SPONGES WAS RECEIVED FOR EVALUATION. UPON VISUAL EXAMINATION THE SPONGES RECEIVED WERE NOT UNIFORM AS WHEN PRODUCED AND THE BAND WAS NOT AVAILABLE TO DETERMINE THE EXACT MACHINE IN WHICH THE SPONGES WERE PRODUCED. THE COUNT OF THE SPONGES REVEAL ELEVEN SPONGES. THE REPORTED CONDITION IS CONFIRMED. THE RETURNED PRODUCT DID NOT MEET QUALITY RELEASE SPECIFICATIONS. THE POSSIBLE ROOT CAUSE MAY BE THE SCALE CHALLENGE FOR WEIGHT COUNT WAS NOT SET UP CORRECTLY ON AUTOBANDERS, ADDED VARIABLES SUCH AS MATERIAL VARIANCES COULD HAVE CONTRIBUTED TO A WEIGHT FAILURE FOR THE SCALE ON THE AUTOBANDERS. A POSSIBLE ROOT CAUSE MAY BE ATTRIBUTED TO THE WEIGHT COUNT IF IT WAS NOT SET UP CORRECTLY ON THE AUTOBANDER. ADDED VARIABLES COULD HAVE CONTRIBUTED TO A WEIGHT FAILURE FOR THE SCALE ON THE AUTOBANDERS. THE PRODUCT ORIGINATES FROM THE MANUFACTURING SITE AND THEN GOES TO ANOTHER SOURCE TO BE USED OR PROCESSED. 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. BUNDLE COUNTS ARE PERFORMED FOR MISCOUNTS PER VALID SAMPLING PLANS ON EACH LOT PRODUCED. 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 ADJUSTED TO TIGHTEN THE BANDS. THE CAPA HAS BEEN IMPLEMENTED TO OPTIMIZE THE AUTOBANDER PROCESS. A ROTATION OF STACKED SPONGES WILL BE REMOVED FROM THE PROCESS AND VALIDATION ACTIVITIES WILL BE PERFORMED. THIS CAPA IS CURRENTLY IN PROGRESS. 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 ARE CURRENTLY BEING PERFORMED AT A HEIGHTENED LEVEL FOR PRODUCTS PACKAGED USING BANDED 10 UNITS FOR MISCOUNT. THIS HEIGHTENED TESTING IS PERFORMED TO ENSURE CONTAINMENT FOR THE REPORTED CONDITION.