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 Insufficient Information (4580)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

No further information is available on the product at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.Device not returned.

Event Description

Aspen surgical received a report from the distributor indicating that marking pen was discovered with a sealing issue.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 243723.(b)(4), lot 241548.

• 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: 12076836
• MDR Text Key: 261508954
• Report Number: 1836161-2021-00028
• 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: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2021
• 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