FDA.reportPublic FDA data

MAUDE MDR 8514336

MDR report key
8514336
Report number
8514336
Event key
0
Event type
3
Date of event
2019-03-25
Date received
2019-04-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BARD-PARKER STAINLESS STEEL BLADE #10BLADE, SCALPELASPEN SURGICAL, INC.GES* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-150

Event Narratives#

D

Patient 1

THE 10 BLADE IN IT'S BARD-PARKER ORIGINAL PACKAGING IS CONTAINED IN ONE OF OUR SURGICAL PACKS. WHEN THE SCRUB NURSE BEGAN PEELING OPEN THE OUTER METAL PACKAGING, THE INNER PAPER PACKAGING OVER BLADE DID NOT PEEL BACK ON EITHER SIDE TO EXPOSE THE BLADE. BLADE WITH PACKAGING PASSED OFF STERILE FIELD AND ADDITIONAL BARD PARKER 10 BLADE OBTAINED FROM SUPPLY CART AND OPENED ON STERILE FIELD. STAFF REPORTED THE SAME EVENT ON PRIOR PROCEDURE BUT THE SCRUB USED HEAVY SCISSORS TO CUT BLADE OUT OF PACKAGING.