MAUDE Adverse Event Report: CAREFUSION, INC PLEURX; APPARATUS, SUCTION, PATIENT CARE

Catalog Number	50-7050
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, upon opening the pleurx pleural catheter mini kit packaging, prior to insertion, a small strand of hair was found inside.This occurred prior to insertion in the patient.
Additional Manufacturer Narrative
H11: the lot number for the device was provided.The device history records are currently under review.A photo was provided; photo review is currently underway.The sample was not returned for evaluation.The investigation is currently underway.Upon completion of the investigation, a supplemental report will be filed.D4 (expiration date is unknown).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 on (b)(6) 2025, upon opening the pleurx pleural catheter mini kit packaging, prior to insertion, a small strand of hair was found inside.This occurred prior to insertion in the patient.Based on further customer response, it was reported that the packaging was not damaged and was properly sealed prior to finding the hair.The packaging with the hair wasn't used on the patient.A new insertion kit was used for patient treatment.
Additional Manufacturer Narrative
H11: a review of the device history record found no related nonconformances, rejections, or issues at release.The physical sample was not returned.One customer photo was provided and reviewed.The photo confirmed the presence of a hair inside the sealed pouch.Therefore, the result of the investigation is confirmed for the reported foreign matter.An internal investigation has been initiated to assess the reported defect to enhance process robustness and prevent recurrence.The complaint will be monitored through the quality data analysis process.B5 (describe event or problem), d4 (expiration date), 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
• Common Device Name: APPARATUS, SUCTION, PATIENT CARE
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: brett curtice_ ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 23969352
• Report Number: 1423507-2026-00001
• Device Sequence Number: 7829949
• Product Code: DWM
• UDI-Device Identifier: 10885403075988
• UDI-Public: (01)10885403075988(10)0001502680
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 02/19/2026

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: 50-7050
• Device Lot Number: 0001502680
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown