MAUDE Adverse Event Report: CAREFUSION, INC THORA/PARA TRAY, 5 FR; THORACENTESIS TRAY

Catalog Number	TPT1005
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the catheter would not advance off the needle with out much force by the md.When he tried to loosen it the plastic catheter slid off and then when it moved back the catheter tore on the needle.There were no reported patient injuries, delays in treatment, or the need for any medical intervention, including diagnostics or procedures.The defective kit was discarded, and the procedure was successfully completed using a new kit.
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: two photo samples were provided to our quality team for investigation.The photos are of the tray packaging.Unable to confirm the reported failure based on the provided photos.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 by the customer that the catheter would not advance off the needle with out much force by the md.When he tried to loosen it the plastic catheter slid off and then when it moved back the catheter tore on the needle.There were no reported patient injuries, delays in treatment, or the need for any medical intervention, including diagnostics or procedures.The defective kit was discarded, and the procedure was successfully completed using a new kit.

• Brand Name: THORA/PARA TRAY, 5 FR
• 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: 22071967
• Report Number: 1625685-2025-00047
• Device Sequence Number: 15827800
• Product Code: PXI
• UDI-Device Identifier: 10885403220852
• UDI-Public: (01)10885403220852(11)250206(17)270131(10)0001608365
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 06/27/2025

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: TPT1005
• Device Lot Number: 0001608365
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2025
• 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