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 Unsealed Device Packaging (1444)

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

Event Date 02/22/2021

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 provided for review.The distributor indicated that the defects were found during incoming inspection.A review of the samples 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.Customer provided samples for evaluation confirming components in the seal.During the production of this lot, the most likely event is the patient label dropped from the pick and place system.Type of fluttering components can occur when the machine is suddenly stopped or when the machine inadvertently dispenses extra components.The root cause for this event is machine issue.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.Customer reported multiple lots for the same issue.The lot numbers and their respective complaint numbers are as follows: (b)(4), lot 235468; (b)(4), lot 234887.

• 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: 11544481
• MDR Text Key: 246657490
• Report Number: 1836161-2021-00012
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2650
• Device Lot Number: SEE ABOVE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2021
• 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