MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA RICHARD-ALLAN REGULAR TIP PEN W/ RULER AND 6-UP LABELS; MARKING PEN

Model Number 2650

Device Problem Defective Component (2292)

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

Event Date 11/15/2020

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 returned for evaluation.Photographic evidence along with the manufacturing lot number were also provided for review.The distributor indicated that the defects were found during incoming inspection.A review of the photos and sample 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.According to the manufacturing process, these parts are loaded into recessed pockets on a packaging machine per specified work instructions.Patient labels and rulers are loaded into the machine by an automated auto-loader, which dispenses each component into the pocket.If incorrectly loaded or not orientated properly, the product interferes with the sealing process.The product that was evaluated was determined that the machine caused the parts to drop from too high of a height.This caused the product to not be placed correctly.Therefore, the likely root cause is attributed to machine issue.This issue was improved with an update to the pneumatic cylinder to allow for more control of the drop height into the pocket for better product placement.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.Customer reported multiple lots for the same issue.The lot numbers and their respective complaint numbers are as follows: (b)(4), lot 233293.(b)(4), lot 223954.

• Brand Name: RICHARD-ALLAN REGULAR TIP PEN W/ RULER AND 6-UP 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: 11002210
• MDR Text Key: 223623145
• Report Number: 1836161-2020-00061
• 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: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2650
• Device Lot Number: SEE ABOVE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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