MURANAKA SURGICAL MARKING PEN, STERILE MMI02730PBX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-19 for MURANAKA SURGICAL MARKING PEN, STERILE MMI02730PBX manufactured by Aspen Surgical Products, Caledonia.

Event Text Entries

[138562147] Aspen surgical received a report from the distributor indicating that a marking pen was discovered with sheet labels in the seal of the pouch. The actual device was returned for evaluation. The manufacturing lot number was also provided for review. A review of the sample confirmed the issue discovered by the distributor. Analysis of the finished good lot number was reviewed. No non-conformance's for this issue were noted during the manufacturing process. This product is packaged on a machine where rulers and labels are auto-loaded and the markers are manually loaded into the recess pockets of the form, fill, and seal machine. This machine can lead to mis-aligning of material in the pockets and the operator checks for alignment (seated) within the pockets. Therefore, the root cause for the sealing error are attributed to operator error. Production supervisors and operations were notified of this issue during the daily update meetings. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10


[138562148] Aspen surgical received a report from the distributor indicating that a surgical marking pen was discovered with a sealing defect. The item was not in use. No injury/death was reported. This report was filed in our complaint handling system as number (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1836161-2019-00015
MDR Report Key8349468
Date Received2019-02-19
Date of Report2019-01-24
Date of Event2018-12-14
Date Mfgr Received2019-01-24
Device Manufacturer Date2018-04-18
Date Added to Maude2019-02-19
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 Report0

Device Details

Brand NameMURANAKA SURGICAL MARKING PEN, STERILE
Generic NameMARKING PEN
Product CodeFZZ
Date Received2019-02-19
Model NumberMMI02730PBX
Lot Number161469
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerASPEN SURGICAL PRODUCTS, CALEDONIA
Manufacturer Address6945 SOUTHBELT DR. S.E. CALEDONIA MI 49316 US 49316


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-19

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