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

Model Number 2630

Device Problem Unsealed Device Packaging (1444)

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

Event Date 05/05/2021

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.A review of the sample confirmed the reported problem of part in seal.The patient labels are loaded into a magazine, these allow for the component alignment into the pockets during the dispensing process.During consultation with the subject matter expert (sme), these components can slide out of the seated pocket and have a high tendency for static friction leading to potential delay in dispensing from the loader itself.This is because the product likes to cling to itself leading to an improper dispense of the component.Although the root cause could not be confirmed, this the likely event that caused the issue.Production team was notified of the reported event.Based on this information, no further action is required.

Event Description

Aspen surgical received a report from the distributor indicating that a pen was discovered with a sealing issue.The item was not in use.No injury/death was reported.This report was filed under our complaint handling system as number (b)(4).

• Brand Name: RICHARD-ALLAN FINE TIP W/ RULER AND 6-UP LABELS- STERILE
• 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: 11893566
• MDR Text Key: 256039292
• Report Number: 1836161-2021-00022
• 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: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2630
• Device Lot Number: 241121
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2021
• 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