MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-12-31 for VENTRICULAR CANNULA DANDY FF124R manufactured by Aesculap Ag.
[131782606]
(b)(4). Date of manufacture is 02/2018 (month/year) day of month is unknown. Investigation results: initial reporter indicated six devices of the same lot number exhibited the reported sharp edge at the drill hole/perforation. Six devices were returned for investigation. Three were in an open and used condition, the other three were returned unused in the original package. The three opened devices all have different manufacture dates, which indicates they are from different lots and none of them share the same manufacture date / lot number of the products returned in package (all three packaged are from same lot number). The device related to this medwatch report was visually and microscopically investigated. It was determined that this device displayed visible damage, including perforations. Latex examination gloves were used to determine if the perforation has a sharp edge; the glove was not damaged. The lot number of this device was not provided, therefore, review of device history records for this lot number could not be completed. Review of device quality and manufacturing records were checked for the reported lot number (4509784027) and were found to be according to specification valid at the time of production. No similar incidents were reported for this batch number. The damage present on this device may have resulted from improper handling, or may have been caused by another instrument. According to the instructions for use (ifu), the following must be observed: safe handling and preparation: - prior to each use, inspect the product for loose, bent, broken, cracked, worn or fractured components. - do not use the product if it is damaged or defective. Set aside the product if it is damaged. Inspection, maintenance and checks: - repeat cleaning and disinfection of products that still show impurities or contamination - check that the product functions correctly.
Patient Sequence No: 1, Text Type: N, H10
[131782607]
It was reported that a surgeon has 6 ventricular cannulas that have a sharp edge at the drill hole / perforation that could lead to brain tissue injury when the cannula is retracted. There was no patient injury associated with these devices. All are reported as the same lot/batch number. All medwatch reports associated with this report include: 9610612-2018-00611 (this report); 9610612-2018-00622; 9610612-2018-00623; 9610612-2018-00624; 9610612-2018-00625; 9610612-2018-00626.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00611 |
| MDR Report Key | 8206775 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-31 |
| Date of Report | 2018-12-31 |
| Date of Event | 2018-12-06 |
| Date Facility Aware | 2018-12-18 |
| Date Mfgr Received | 2018-12-07 |
| Device Manufacturer Date | 2018-02-01 |
| Date Added to Maude | 2018-12-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENTRICULAR CANNULA DANDY |
| Generic Name | CANNULA |
| Product Code | HCD |
| Date Received | 2018-12-31 |
| Returned To Mfg | 2018-12-18 |
| Model Number | FF124R |
| Catalog Number | FF124R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-31 |