MAUDE Adverse Event Report: CAREFUSION, INC THORACENTESIS/PARACENTESIS TRAY; THORACENTESIS TRAY

Catalog Number	TPT1000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Verbatim: we are having issues with kit tpt1000.Three times this week, the introducer needle with stopcock has broken which is causing staff to open another tray.No medical intervention required including diagnostics, procedures, and treatment delay.
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.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.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 we are not able to identify a root cause at this time.H11: h6: annex b (type of investigation), annex c (investigation findings), annex d (investigation conclusions), annex g (component code) h10: b5 (describe event or problem), g4 (date received by manufacturer), g7 type or report - follow up# 1), h2 (correction and additional information).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 we are having issues with kit tpt1000.Three times this week, the introducer needle with stopcock has broken which is causing staff to open another tray.No medical intervention required including diagnostics, procedures, and treatment delay.

• Brand Name: THORACENTESIS/PARACENTESIS TRAY
• Common Device Name: THORACENTESIS TRAY
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• 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: 22312177
• Report Number: 1625685-2025-00055
• Device Sequence Number: 15652019
• Product Code: PXI
• UDI-Device Identifier: 10885403108488
• UDI-Public: (01)10885403108488(11)250211(17)270131(10)0001608875
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 07/01/2025

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: TPT1000
• Device Lot Number: 0001608875
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2025
• 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