MAUDE Adverse Event Report: CAREFUSION, INC PLEURX DRAINAGE KIT 1000ML; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Catalog Number	50-7510
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: a lot number was provided so a device history record is currently underway.Photos were provided and review is currently pending.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: k160437; k160450; k201155; k241946.D2b: pro code: dwm; png.Section a through f ¿ the information provided 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 customer that on (b)(6) 2026, the during routine pleurx drain care, staff noticed a wet spot on the sterile drape.Upon inspection, they found that the tubing attached to the pleurx bottle was leaking fluid onto the sterile field.The drainage procedure was stopped, the leaking bottle was disconnected, and a new bottle available in the home was attached.The device involved was not implanted and not retained.No patient injury was reported.During follow up response it was further reported that the leakage occurred between the distal end of the access tip and the attached drainage line.There was no damage noted to the access tip or the patient's valve.The patient's catheter is an abdominal pleurx on their right side.Due to the leakage, bodily fluid leaked on to patient's lap, saturating a small portion of their pants and on to their chair.
Event or Problem Description
It was reported by customer that on (b)(6) 2026, the during routine pleurx drain care, staff noticed a wet spot on the sterile drape.Upon inspection, they found that the tubing attached to the pleurx bottle was leaking fluid onto the sterile field.The drainage procedure was stopped, the leaking bottle was disconnected, and a new bottle available in the home was attached.The device involved was not implanted and not retained.No patient injury was reported.During follow up response it was further reported that the leakage occurred between the distal end of the access tip and the attached drainage line.There was no damage noted to the access tip or the patient's valve.The patient's catheter is an abdominal pleurx on their right side.Due to the leakage, bodily fluid leaked on to patient's lap, saturating a small portion of their pants and on to their chair.
Additional Manufacturer Narrative
H11: two photo samples were provided to our quality team for investigation.Upon visual inspection of the photos, a leak was observed at the interface between the access dilator and the drainage line tubing.The images suggest an incomplete bond at this connection point.Specifically, there appears to be insufficient application of solvent, glue during the manufacturing process, which likely resulted in a gap between the tubing and the access dilator.Based on the visual inspection performed, the failure mode is consistent with an inadequate solvent, glue application at the tubing to access dilator connection.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001631079 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Based on the quality team¿s investigation, a potential root cause for this failure mode was identified as either a human factor issue or a manufacturing assembly error.The appropriate personnel have been notified, and awareness and reinforcement actions have been implemented to ensure adherence to assembly requirements and minimize the likelihood of recurrence.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.G3 (date received by manufacturer), g6 type or report - follow up# 1), h2 (correction and additional information), h6: annex g (component code), annex b (type of investigation), annex c (investigation findings), annex d (investigation conclusions).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.

• Brand Name: PLEURX DRAINAGE KIT 1000ML
• 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: 24434796
• Report Number: 1423507-2026-00033
• Device Sequence Number: 21408483
• Product Code: PNG
• UDI-Device Identifier: 10885403090707
• UDI-Public: (01)10885403090707(17)280101(10)0001631079
• Combination Product (Y/N): N
• 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): 03/25/2026

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: 50-7510
• Device Lot Number: 0001631079
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown