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

Catalog Number	50-7500B
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: the lot number for the device was provided.The device history records are currently under review.The device has not been returned.The investigation is currently underway.H10 : d4 (expiration date: 11/2026).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
Injury (patient / other): no.Device possibly involved in injury: no.Device available for examination: no.Detection site: 2 - on application.Origin: patient.Complaint: 0.1ve: foil / packaging not sealed at the bottom.Product was discarded because it was not sterile packed.Information on the defect: defect location: sterile packaging type of error: not correct / uniform / consistent (faulty) defect location: vacuum flask type of defect: damaged (broken, brittle, deformed).
Event or Problem Description
It was reported that the foil / packaging not sealed at the bottom.Product was discarded because it was not sterile packed.There was no reported patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a review of the internal manufacturing device records and raw material history files for the reported lot number 0001569575 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.H10: investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.Based on the available information a probable root cause for this reported failure mode could not be established since it was not provided enough information to fully investigate this incident.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 b (type of investigation), annex c (investigation findings), annex d (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.

• 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: 21981319
• Report Number: 9680904-2025-00007
• Device Sequence Number: 14518914
• Product Code: DWM
• UDI-Device Identifier: 10885403090714
• UDI-Public: (01)10885403090714
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: 0001569575
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2024
• 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