CARBON STEEL SCALPEL BLADES #10 BB510

MAUDE Adverse Event Report

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.

Event Text Entries

[144968591] (b)(4). Manufacturing site evaluation: thirty-six unopened dispenser packaging of lot 4510101361, were received. They arrived in a decontaminated condition and they are available for investigation. Investigation - the investigation was carried out visually and microscopically. 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


[144968592] 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


MAUDE Entry Details

Report Number9610612-2019-00315
MDR Report Key8601508
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-05-10
Date of Report2019-05-10
Date of Event2019-01-01
Date Facility Aware2019-05-03
Date Mfgr Received2019-04-15
Device Manufacturer Date2018-10-13
Date Added to Maude2019-05-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LINDSAY CHROMIAK
Manufacturer Street3773 CORPORATE PARKWAY
Manufacturer CityCENTER VALLEY PA 18034
Manufacturer CountryUS
Manufacturer Postal18034
Manufacturer G1AESCULAP AG
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal Code78501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARBON STEEL SCALPEL BLADES #10
Generic NameBASIC INSTRUMENTS
Product CodeGES
Date Received2019-05-10
Returned To Mfg2019-04-29
Model NumberBB510
Catalog NumberBB510
Lot Number4510101361
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age80 DA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-10

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