MAUDE Adverse Event Report: CAREFUSION, INC THORA/PARA TRAY, 5FR, NON-VALVED; Thoracentesis Tray

Catalog Number	OTP5000
Medical Device Problem Codes	Dull, Blunt (2407); Failure to Advance (2524)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: the lot number was not provided; a review of the device history records could not be performed.Photos were not provided for review.The device has not been returned.Upon completion of the investigation, a supplemental report will be filed.B3 (date of event) the actual date of event is unknown.The date received by manufacturer (awareness date) was entered into the date of event field.D4 (expiration date is unknown), h4 (device manufacturing 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 multiple thora/para needles were unable to pierce the skin without a pre-cut nick.Following initial skin access, the needles advanced roughly through the tissue, described as similar to a catheter accordion effect or the cannula edge catching on tissue rather than advancing smoothly.There is no device to return for evaluation.

• Brand Name: THORA/PARA TRAY, 5FR, NON-VALVED
• Common Device Name: Thoracentesis Tray
• 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: michael gaffney ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 25694587
• Report Number: 1423507-2026-00098
• Device Sequence Number: 9875594
• Product Code: PXI
• UDI-Device Identifier: 10885403284748
• UDI-Public: (01)10885403284748
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2026

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: OTP5000
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Supplement Date Received by Manufacturer: 07/31/2026; 07/31/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 08/04/2026; 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown