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 2019-04-02 for CARBON STEEL SCALPEL BLADES #10 BB510 manufactured by Aesculap Ag.

Event Text Entries

[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


MAUDE Entry Details

Report Number9610612-2019-00218
MDR Report Key8476220
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-04-02
Date of Report2019-04-02
Date Facility Aware2019-03-26
Date Mfgr Received2019-03-06
Device Manufacturer Date2018-06-19
Date Added to Maude2019-04-02
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. NICOLE BROYLES
Manufacturer Street615 LAMBERT POINTE DRIVE
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145515988
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 NameGENERAL SURGICAL INSTRUMENTS
Product CodeGES
Date Received2019-04-02
Model NumberBB510
Catalog NumberBB510
Lot Number4509537648
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2019-04-02

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