MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. DR FOG TREATED SPONGE, STERILE; ANTI-FOG

Model Number	DF-3120
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Aspen surgical received a report from the distributor indicating that product was found with seal issues.The actual device is available for evaluation, and the manufacturing lot number was provided for review.The investigation is ongoing.If any additional relevant information is identified, the additional relevant information will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "sterilization breach, as seal was open.".
Additional Manufacturer Narrative
After the investigation, it was determined that the sponge was caught in the seal (seal interference).During manufacturing, if the sponge is curled it can get kicked over into the sealing area as the pouch moves through the packaging machine.The work instruction details a curled or bent sponge should be removed during the pouching operation to mitigate the sponge from being caught in the seal during sealing.Operators box product and inspect product/pouches as they are packaging the finished product, and this was not detected in this case.The root cause was a manufacturing error.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: DR FOG TREATED SPONGE, STERILE
• Common Device Name: ANTI-FOG
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 20532774
• Report Number: 3002750084-2024-00043
• Device Sequence Number: 20894950
• Product Code: OCT
• UDI-Device Identifier: 00840113206926
• UDI-Public: 00840113206926
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K932449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: DF-3120
• Device Lot Number: 402664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown