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 2019-05-10 for CARBON STEEL SCALPEL BLADES #10 BB510 manufactured by Aesculap Ag.
[144968768]
(b)(4). Manufacturing site evaluation: one hundred and fifty-eight unopened dispenser packaging of lot 4509861453, and one opened dispenser packaging of the same lot were received. They arrived in a decontaminated condition and they are available for investigation. Investigation - the investigation was carried out visually and microscopically. We made a visual inspection of the opened dispenser packaging. Here we found holes or cracks at the packing. We also made an optical inspection of the arrived unopened dispenser packaging. Here we detected no visible damaged dispenser packaging of the package. There were some found with suspected visible damage. Furthermore, the products were sent to the production department for further investigations. The report will be updated when we receive a statement from that department. Batch history review - the device quality and manufacturing history records will be checked for the lot number. Once the quality coordinator of the production plant checks it, the report will be updated. No similar incidents have been filed with products from these batches. Conclusion and root cause - there is the possibility that the root cause of the problem is related to an improper transport of the product. The report will be updated after further investigation from the production department. Rationale - due to the circumstance that the products have been sent to the manufacturer for an analysis, this is a preliminary report. There is the possibility that the holes or cracks and suspected visible damage were caused due to an improper transport of the product. There is also the possibility that the cause could be traced back to an increased load, e. G. Drops, impacts or similar, during transport. A capa was initiated and completed.
Patient Sequence No: 1, Text Type: N, H10
[144968769]
It was reported that there was an issue with the scalpel package. Prior to surgery, it was noted that there was a hole or crack in the sterile packet. The device was not used on a patient. There was no additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00314 |
| MDR Report Key | 8601507 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-10 |
| Date of Report | 2019-05-10 |
| Date of Event | 2019-01-01 |
| Date Facility Aware | 2019-05-03 |
| Date Mfgr Received | 2019-04-15 |
| Date Added to Maude | 2019-05-10 |
| 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 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 #10 |
| Generic Name | BASIC INSTRUMENTS |
| Product Code | GES |
| Date Received | 2019-05-10 |
| Returned To Mfg | 2019-04-29 |
| Model Number | BB510 |
| Catalog Number | BB510 |
| Lot Number | 4509861453 |
| 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 | 2019-05-10 |