MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. S-VAC SILICONE BULB EVACUATOR, 100 ML, STERILE

Model Number	322160
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 "the sterile packaging is open.".
Additional Manufacturer Narrative
Despite many attempts, we were unable to obtain the actual device.However, pictures and product informatiion like part number and lot number were provided.The pictures provided showed an open seal.We did not get a physical sample, but the most likely cause is that product was in the seal as these bulbs are wrapped in a bag that is loaded into the pocket.If the wrapped product is not set in the pouch correctly, the product could end up in the seal causing an open seal.The primary root cause is most likely machine/process error, while a contributing factor may be human error due to the manual nature of inspection.If any additional relevant information is identified, it will be provided in a supplemental report.

• Brand Name: S-VAC SILICONE BULB EVACUATOR, 100 ML, STERILE
• Common Device Name: BULB EVACUATOR
• 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: 20579637
• Report Number: 3002750084-2024-00045
• Device Sequence Number: 8649815
• Product Code: GCY
• UDI-Device Identifier: 00840113224715
• UDI-Public: 00840113224715
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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): 02/05/2025

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: 322160
• Device Lot Number: 409984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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