MAUDE Adverse Event Report: CAREFUSION, INC SAFE-T-CENTESIS TRAY 8FR X 16CM; THORACENTESIS TRAY

Catalog Number	PIG1280T
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: b3: date of event: the date of awareness was entered in the date of event field as the actual date of event is unknown.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 the safe-t-centesis tray kit catheter was difficult to deploy.It was further reported that a plastic piece was found on the tip of the needle when the catheter was pushed through.There was no reported patient injury.
Event or Problem Description
It was reported that the safe-t-centesis tray kit catheter was difficult to deploy.It was further reported that a plastic piece was found on the tip of the needle when the catheter was pushed through.There was no reported patient injury.
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 0001572285 was performed and no recorded quality problems or rejections related to this incident were found.The product was inspected 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: one veress needle and one catheter was received by our quality team for evaluation.During evaluation a particulate (foreign matter) was observed.Therefore, the reported foreign matter failure mode was confirmed but the root cause is unknown.H10: b5 (describe event or problem), d10 (device available for eval; returned to manufacturer on), g4 (date received by manufacturer), g7 type or report - follow up# 1), h2 (correction, additional information, and device evaluation).H11: h3 (device eval by manufacturer), h6 (type of investigation, investigation findings, and 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: SAFE-T-CENTESIS TRAY 8FR X 16CM
• 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: 21911513
• Report Number: 1625685-2025-00035
• Device Sequence Number: 20649797
• Product Code: PXI
• UDI-Device Identifier: 10885403108402
• UDI-Public: (01)10885403108402(11)240606(17)260331(10)0001572285
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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 Expiration Date: 03/31/2026
• Device Catalogue Number: PIG1280T
• Device Lot Number: 0001572285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown