MAUDE Adverse Event Report: PFM MEDICAL, INC. ASEPT; BOTTLE, COLLECTION, VACUUM

Model Number	M7052
Medical Device Problem Codes	Off-Label Use (1494); Suction Problem (2170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed and no deviations were observed.There were no non-conformance's or capas that were identified that could have contributed to the reported issue.The product and materials met all requirements.No similar complaints for this product have been received.The retained product from the production lot was evaluated and found to still have vacuum as demonstrated by the vacuum indicator.The risk of this issue is covered in the risk assessment.No trend has been identified.The ifu was reviewed and found that the product was used off label.The product is indicated for pleural and peritoneal drainage.The product was used for a therapeutic phlebotomy which is off label use.The root cause of this issue is use error.
Event or Problem Description
Canister initially started to pull blood but then seemed to reverse back into the patient.Clinical teams were alerted to monitor patient.What was the original intended procedure? therapeutic phlebotomy.What problem did the user have: device failed (e.G.Broke, couldn't get it to work or stopped working).

• Brand Name: ASEPT
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): PFM MEDICAL, INC.; 1916 palomar oaks way; suite 150; carlsbad CA 92008
• Manufacturer (Section G): PFM MEDICAL, INC.; 1916 palomar oaks way; suite 150; carlsbad CA 92008
• Manufacturer Contact: troy taylor ; 1916 palomar oaks way; suite 150; carlsbad, CA 92008 ; 7607588749
• MDR Report Key: 21527940
• Report Number: 3013666218-2025-00001
• Device Sequence Number: 7735267
• Product Code: KDQ
• UDI-Device Identifier: 00813623015746
• UDI-Public: 00813623015746
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2025

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 Expiration Date: 01/25/2026
• Device Model Number: M7052
• Device Catalogue Number: M7052
• Device Lot Number: 2308-047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic