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 2019-05-31 for CARBON STEEL SCALPEL BLADES #22 BB522 manufactured by Aesculap Ag.
[147164820]
(b)(4). Investigation: the peel packaging of the blades are not sealed correctly. One side of the peel is open, the anti-corrosion-inlay is not at the right position. Batch history review: the device quality and manufacturing history record have been checked for the available lot number and found to be according to our specifications valid at the time of production. No similar incidents have been filed with products from this batch. Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to a manufacturing error. Rationale: the detected error can be attributed to a production error.
Patient Sequence No: 1, Text Type: N, H10
[147164821]
It was reported the packages had insufficient sealing. The reporter indicated that in almost every case the packages of the scalpel blades were completely open. The blades were falling out of the package. This event was noticed prior to surgery, therefore no harm to the patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00363 |
| MDR Report Key | 8660347 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-31 |
| Date of Event | 2019-05-02 |
| Date Facility Aware | 2019-05-21 |
| Date Mfgr Received | 2019-05-02 |
| Device Manufacturer Date | 2018-11-22 |
| Date Added to Maude | 2019-05-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LINDSAY CHROMIAK |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer Phone | 8002581946 |
| 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 | CARBON STEEL SCALPEL BLADES #22 |
| Generic Name | BASIC INSTRUMENTS |
| Product Code | GES |
| Date Received | 2019-05-31 |
| Returned To Mfg | 2019-05-15 |
| Model Number | BB522 |
| Catalog Number | BB522 |
| Lot Number | 4509960181 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 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 | 2019-05-31 |