MAUDE Adverse Event Report: ORIGEN BIOMEDICAL, INC PERMALIFE CELL CULTURE BAG; PERMALIFE CELL CULTURE BAG, 120ML, WITH SCD TUBING

Catalog Number	PL120N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was a pinhole that led to material leakage from a pl120n cell culture bag following removal of the bag from incubation.This leakage led to the batch of product to be terminated and a subsequent delay in patient treatment greater than 24 hours.

• Brand Name: PERMALIFE CELL CULTURE BAG
• Common Device Name: PERMALIFE CELL CULTURE BAG, 120ML, WITH SCD TUBING
• Manufacturer (Section D): ORIGEN BIOMEDICAL, INC; 7000 burleson rd; building d; austin TX 78744
• Manufacturer (Section G): ORIGEN BIOMEDICAL, INC; 7000 burleson rd; building d; austin TX 78744
• Manufacturer Contact: sam saleh ; 7000 burleson road; building d; austin, TX 78744 ; 5124747278
• MDR Report Key: 20870086
• Report Number: 1000160256-2024-00008
• Device Sequence Number: 7850884
• Product Code: LPZ
• UDI-Device Identifier: 10816203023244
• UDI-Public: 10816203023244
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K021702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PL120N
• Device Lot Number: W23974
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown