RICHARD-ALLAN REGULAR TIP PEN W/ RULER 2650

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-13 for RICHARD-ALLAN REGULAR TIP PEN W/ RULER 2650 manufactured by Aspen Surgical Products, Caledonia.

Event Text Entries

[111688299] Aspen surgical received a report from the distributor indicating that product was found in the seal of the pouch. The actual device was not returned for evaluation. The manufacturing lot numbers along with photographic evidence was provided for review. The lot numbers associated with the report are as follows: 150264, 138917. The distributor indicated that the defects were found during incoming inspection. A review of the photos confirmed the issue from the distributor. Analysis of the finished good lot numbers were reviewed. No non-conformance's were noted during the manufacturing process. According to the manufacturing process, these parts are manually loaded into recessed pockets on a packaging machine per specified work instructions. If incorrectly loaded or not orientated properly, the product interferes with the sealing process. Therefore a likely root cause for the parts in the seal may be attributed to an operator error. The ifu, along with the pouch label, identifies this failure mode with the symbol "do not use if package is damaged". This indicates that the device should not be used if the products sterile barrier system or its packaging is compromised. Additionally, production supervisors were notified of this issue during the daily update meetings. Based on this information, no further action is required. Device not returned.
Patient Sequence No: 1, Text Type: N, H10


[111688300] Aspen surgical received a report from the distributor indicating that richard-allan regular tip pen was found with the product in the seal of the pouch. The item was not in use. No injury/death was reported. This report was filed in our complaint handling system for multiple lot numbers. The complaint references for these lot numbers are as follows: (b)(4) - lot 150264, (b)(4) - lot 138917.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1836161-2018-00056
MDR Report Key7597278
Date Received2018-06-13
Date of Report2018-05-21
Date of Event2018-04-04
Date Mfgr Received2018-05-21
Date Added to Maude2018-06-13
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 NameRICHARD-ALLAN REGULAR TIP PEN W/ RULER
Generic NameMARKING PEN
Product CodeFZZ
Date Received2018-06-13
Model Number2650
Lot NumberSEE ABOVE
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
10 2018-06-13

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