MAUDE Adverse Event Report: CAREFUSION, INC PLEURX DRAINAGE KIT 500ML 10/CS; APPARATUS, SUCTION, PATIENT CARE

Catalog Number	50-7500B
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that halfway using the pleurx bottle product, the tubing of the plunger disconnected causing a blood leakage from the drainage line and valve of the catheter and spilled everywhere.There was no reported patient injury.
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.D2b: pro code: dwm; png, g4: pma / 510(k)#: k160437; k160450; k201155; k971753.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.
Additional Manufacturer Narrative
H11: the lot number was provided, so a device history record review was performed.A review of the internal manufacturing device record and raw material history files for the reported lot number was performed and no recorded quality problems or rejections related to this incident were found.It was confirmed that procedural and functional requirements needed for its release were met.Physical samples were not received for analysis.Three photos were received from the customer for evaluation.A visual inspection was performed on the images provided.The first photo showed a pleurx bottle, where the drainage line tube appeared to be partially disconnected.The second photo displayed the kit label.Through the package label, it was possible to confirm that the code 50-7500b and lot 0001588197 match our records.The third photo showed a pleurx bottle where the drainage line tube is not assembled into the bottle port.No traces of solvent or adhesive are observed on the white t plunger.Based on the visual inspection performed, the failure mode could be confirmed.A potential root cause for this failure move is manufacturing related.This complaint and entered into the tracking system and is being tracked for future occurrences of any similar issues.B5 (describe event or problem), g3 (date received by manufacturer), g6 type or report - follow up# 1), h2 (correction and additional information), (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.
Event or Problem Description
It was reported that halfway using two pleurx bottle products, the tubing of the plungers disconnected causing a blood leakage from the drainage line and valve of the catheters and spilled everywhere including the health care provider's (hcp) hands, however, the hcp was wearing gloves.It was further reported that the treatment was ceased and attempted again the same afternoon with a third bottle of a different batch to drain the patient.There was no harm or impact to the patient or hcp, and additional medical intervention was not needed.

• Brand Name: PLEURX DRAINAGE KIT 500ML 10/CS
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer (Section G): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer Contact: brett curtice_ ; 75 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 22614711
• Report Number: 9680904-2025-00018
• Device Sequence Number: 9603921
• Product Code: DWM
• UDI-Device Identifier: 10885403090714
• UDI-Public: (01)10885403090714(17)270222(10)0001588197
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: Health Professional
• Device Catalogue Number: 50-7500B
• Device Lot Number: 0001588197
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown