MAUDE Adverse Event Report: CAREFUSION, INC PERITX DRAINAGE BAG; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Catalog Number	50-9210
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: a lot number was provided; the device history records are currently under review.The investigation is currently underway.H3 (device eval by manufacturer) a device has not been returned.Upon completion of the investigation, a supplemental report will be filed.G4: pma/510k : k122422;k160437;k201155;k241946.D2: medical device type: dwm; png.Section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported by the customer on (b)(6) 2026, that the peritx drainage bag was leaking during use, despite confirmation that both the drainage end and the clamp were securely closed.During follow up information received on march 29, 2026, it was further reported that there was no direct patient or healthcare provider injury.The source of the leak could not be clearly identified.The reporter stated that after ensuring the drainage cap was twisted closed, approximately 1000 ml of fluid was collected, the device was disconnected from the patient, the roller clamp was closed, and the pleurx bag was discarded into a garbage bag placed on the floor.Shortly thereafter, an estimated 500 ml of fluid leaked onto the floor.Due to the volume of fluid around the bag, the exact source of the leak could not be visually determined.As the drainage cap and roller clamp had been confirmed closed, the leak was suspected to have originated from the bag itself or possibly from the connection between the bag and the tubing.

• Brand Name: PERITX DRAINAGE BAG
• Common Device Name: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer Contact: brett curtice_ ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 24779862
• Report Number: 1423507-2026-00058
• Device Sequence Number: 6133325
• Product Code: PNG
• UDI-Device Identifier: 10885403222726
• UDI-Public: (01)10885403222726(17)300829(10)0001642276
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: CA
• PMA/510(K) Number: SEE H.11.
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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: Health Professional
• Device Catalogue Number: 50-9210
• Device Lot Number: 0001642276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown