BARD-PARKER SAFETY BLADES SIZE 11, STERILE 373911-150

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-03-11 for BARD-PARKER SAFETY BLADES SIZE 11, STERILE 373911-150 manufactured by Aspen Surgical Products, Caledonia.

Event Text Entries

[138355021] Aspen surgical received a report indicating that a bard-parker blade broke while in use during a procedure. The incident occurred at the user facility. A manufacturing lot number was provided for review. A review of the device history record was completed and no non-conformance's related to the reported issue was identified. The most probable root cause could have been machine related during the stamping or grinding process. Packaging process has established controls to mitigate broken or cracked blade condition, including a "medio" blade sensor that inspects 100% of packed pouches liner level prior to aluminum foil packaging. Also, excessive force applied by the end user during surgery process could cause blade breakage. The following controls are in-place to mitigate "broken blade" condition at aspen surgical las piedras site: heat treatment in-process at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test. Heat treatment quality inspections at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test. No sample was available for return. Based on this information, no further action is required. Device not available.
Patient Sequence No: 1, Text Type: N, H10


[138355022] Aspen surgical received a report from the distributor indicating that a bard-parker blade broke during a procedure. The incident occurred at the user facility. This report was filed in our complaint handling system as complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1836161-2019-00020
MDR Report Key8407366
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-03-11
Date of Report2019-02-11
Date of Event2019-02-07
Date Mfgr Received2019-02-11
Device Manufacturer Date2018-08-31
Date Added to Maude2019-03-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JORDAN HACKERT
Manufacturer Street6945 SOUTHBELT DR. S.E.
Manufacturer CityCALEDONIA MI 49316
Manufacturer CountryUS
Manufacturer Postal49316
Manufacturer Phone6165367508
Manufacturer G1SAME AS ABOVE
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBARD-PARKER SAFETY BLADES SIZE 11, STERILE
Generic NameBARD-PARKER BLADE
Product CodeGES
Date Received2019-03-11
Model Number373911-150
Lot Number0173264
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerASPEN SURGICAL PRODUCTS, CALEDONIA
Manufacturer Address6945 SOUTHBELT DR. S.E. CALEDONIA MI 49316 US 49316


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2019-03-11

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