N
Patient 1
SUBMIT DATE: 09/07/17. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.
MAUDE MDR 6849508
- MDR report key
- 6849508
- Report number
- 9612030-2017-05158
- Event key
- 0
- Event type
- 3
- Date received
- 2017-09-07
- 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 | 2017-09-07 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER STATES THAT THE LEAKING MARKERS ARE CAUSING STAINS.
N
Patient 1
ONE HUNDRED DECONTAMINATED SAMPLES OUTSIDE OF THE ORIGINAL PACKAGE WITHOUT A LOT NUMBER WAS RECEIVED FOR EVALUATION. A SAMPLE ANALYSIS WAS PERFORMED; AS PART OF THE ANALYSIS THE SAMPLE WAS VISUALLY INSPECTED ACCORDING TO THE PRODUCT SPECIFICATION. THE SAMPLES APPEAR TO HAVE A LEAKAGE THROUGH THE AIR HOLES. THE REPORTED CONDITION BY THE CUSTOMER WAS CONFIRMED. THE SKIN MARKER IS A PURCHASED COMPONENT MANUFACTURED BY AN APPROVED VENDOR. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCT THAT COULD HAVE LED TO THE CONDITION DESCRIBED BY THE CUSTOMER. THE DHR REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. THE COMPONENT SKIN MARKER IS PRODUCED BY EXTERNAL SUPPLIER AND THE ASSEMBLY PROCESS CONSISTS OF A PICK AND PLACE OPERATION. THERE IS NO ADDITIONAL INSPECTION ON THE LINE TO DETECT THE CONDITION REPORTED. THE FOLLOWING ROOT CAUSE WAS PROVIDED BY OUR SUPPLIER: INK LEAKAGE WAS FROM AIR HOLE FOR ALL 23 SAMPLES THAT SHOWED INK LEAKAGE. THE POSSIBLE REASONS FOR INK LEAKAGE FROM AIR HOLES ARE: IMPACT FROM DROPPING. DECOMPRESSION. BASED ON THE STATE OF RETURNED SAMPLES AND TEST RESULTS, WE CONCLUDED THAT THE LEAKAGE OC CURRED DUE TO AN IMPACT SUCH AS DROPPING. A PRODUCTION NOTIFICATION WAS ISSUED TO ALL PERSONNEL TO ENSURE THAT THEY ARE AWARE ON THE CONDITION REPORTED BY THE CUSTOMER. THE FOLLOWING CORRECTIVE ACTIONS WERE IMPLEMENTED BY OUR SUPPLIER: THE POSSIBLE REASON FOR DROPPING IN PRODUCTION SITE MAYBE AT PRODUCTION LINE OR DURING TRANSPORTATION. HOWEVER, IT IS UNLIKE THAT DROPPING OCCURS IN THE LINE. WE PALLETIZE THE PRODUCTS SO IT IS UNLIKE TO BE DROPPED DURING TRANSPORTATION. PLEASE INSTRUCT YOUR WORKING MEMBERS AND THE CUSTOMER TO HANDLE WITH CARE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.