N
Patient 1
(B)(4). MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
MAUDE MDR 6378641
- MDR report key
- 6378641
- Report number
- 3003639970-2017-00107
- Event key
- 0
- Event type
- 3
- Date received
- 2017-03-03
- 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
- MS. NICOLE BROYLES
- Address
- 615 LAMBERT POINTE DRIVE HAZELWOOD MO 63042 US
- Phone
- 314-314-3145
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MONOMAX VIOLET 1(4)150CM HR48 LOOP(M) | SUTURES | B.BRAUN SURGICAL SA | NWJ | B0041119 | B0041119 | 116373 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-03-03 | 0 | 1. O |
Event Narratives#
D
Patient 1
COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT THE THREADS ARE STICKY AND THEREFORE IT IS DIFFICULT TO REMOVE THE OUT OF THE PRIMARY PACKAGE.
N
Patient 1
SAMPLES RECEIVED: 16 UNOPENED AND 1 OPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 1,080 UNITS OF THIS BATCH. THERE ARE NO UNITS IN STOCK. WE HAVE RECEIVED 16 CLOSED SAMPLES AND ONE OPEN SAMPLE (ONLY THE SECOND PACK IS OPEN). TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. EXTRACTION OF THE SUTURE IN THE RECEIVED SAMPLES IS CORRECT AND THE CURRENT ONE. SUTURE HAS BEEN PULLED OUT WITHOUT DIFFICULTY AND DOES NOT BECOME TANGLED. WE HAVE CHECKED CAREFULLY ALL SAMPLES RECEIVED AND NO DEFECTS OR IRREGULARITIES HAVE BEEN FOUND. THREAD SURFACE ON THE SAMPLES RECEIVED IS CORRECT AND THE USUAL ONE. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL B.BRAUN SURGICAL REQUIREMENTS. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.