MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA RICHARD-ALLAN REGULAR TIP PEN W/ RULER AND LABELS; MARKING PEN

Model Number 2650

Device Problems Defective Component (2292); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the distributor indicating that product was found with seal issues.The actual device was not returned for evaluation.Photographic evidence along with the manufacturing lot number were provided for review.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 number was reviewed.No non-conformance's were noted during the manufacturing process.This product is autoloaded where the patient label, rulers, and pens are loaded in utilizing automated loading systems.For this event, a patient label was caught in the seal in a lateral direction.This can occur when additional patient labels are dispensed into the pouch due to component static.The machine can also dispense extra components if the machine is abruptly interrupted/stopped.From review of the information provided the root cause of this event cannot be determined, but the event was confirmed.Production supervisors were notified of the event.Based on this information, no further action is required.

Event Description

Aspen surgical received a report from the distributor indicating that a surgical marking pen was found with defective seals.The item was not in use.No injury/death was reported.The report was filed in our complaint handling system under number (b)(4).

• Brand Name: RICHARD-ALLAN REGULAR TIP PEN W/ RULER AND LABELS
• Type of Device: MARKING PEN
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: jordan hackert ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6165367508
• MDR Report Key: 11202590
• MDR Text Key: 232518403
• Report Number: 1836161-2021-00004
• Device Sequence Number: 1
• Product Code: FZZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2650
• Device Lot Number: 233293
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1