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 2019-04-02 for CARBON STEEL SCALPEL BLADES #10 BB510 manufactured by Aesculap Ag.
[140740834]
(b)(4). If additional information is received a follow up report will be submitted. Investigation: no product at hand. Only photos archived. We found that the sterile packaging is open at one side. Batch history review: the device quality and manufacturing history records will be checked for all the lot number (4509537648/4509299706) from the quality coordinator of the production plant. After review the report will be updated. No similar incidents have been filed with products from this batch. Conclusion and root cause: no product available and therefore it is hardly possible to determine an exact conclusion and root cause. There is the possibility that the root cause of the problem is most probably manufacturing related. Rationale: without the product we cannot determine the exact cause but there is the possibility for a manufacturing error due to an improperly manufactured sealing.
Patient Sequence No: 1, Text Type: N, H10
[140740835]
It was reported there is a crack/hole at the sterile package for two different lot numbers. The packaging problem was detected prior to surgery and all sterile packaging was checked with a lamplight. No other information has been provided. Associated medwatches: 9610612-2019-00218 (this report), 9610612-2019-00219.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00218 |
| MDR Report Key | 8476220 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-02 |
| Date of Report | 2019-04-02 |
| Date Facility Aware | 2019-03-26 |
| Date Mfgr Received | 2019-03-06 |
| Device Manufacturer Date | 2018-06-19 |
| Date Added to Maude | 2019-04-02 |
| 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. 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 | CARBON STEEL SCALPEL BLADES #10 |
| Generic Name | GENERAL SURGICAL INSTRUMENTS |
| Product Code | GES |
| Date Received | 2019-04-02 |
| Model Number | BB510 |
| Catalog Number | BB510 |
| Lot Number | 4509537648 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-04-02 |