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

Catalog Number	50-7500B
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced an allergic reaction to alleged plasters after the pleurx drainage procedure.It was further reported that the defect location was the foil bond.Patient additional treatment and patient status is unknown.
Additional Manufacturer Narrative
H10: the lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.H11: 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
H10: manufacturing review: the lot number for the device was provided, and a device history record was performed.A review of the internal manufacturing device records 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.The product was inspected during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release were met.H10: investigation summary: there were no photos provided for review and the physical sample was not received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined at this time.H10: b5 (describe event or problem), g4 (date received by manufacturer), g7 type or report - follow up# 1), h2 (correction and additional information).H11: h6: annex g (component code), (type of investigation, investigation findings, and investigation conclusions).H11: 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 after use of the pleurx drainage kit, the patient experienced an allergic reaction to plasters by the patch in the pleura body location.A substitute product was used to resolve the issue and treat the patient successfully.

• 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 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 22069818
• Report Number: 9680904-2025-00013
• Device Sequence Number: 21175828
• Product Code: DWM
• UDI-Device Identifier: 10885403090714
• UDI-Public: (01)10885403090714(11)240902(17)270219(10)0001587559
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 50-7500B
• Device Lot Number: 0001587559
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown