MAUDE Adverse Event Report: CAREFUSION, INC SAFE-T-CENTESIS TRAY 6FR X 16CM; Thoracentesis Tray

Catalog Number	PIG1260T
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: a lot number was provided; the device history records are currently under review.The investigation is currently underway.H3 (device eval by manufacturer) a 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.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 a trauma intensive care unit (ticu) physician assistant (pa) that there was an issue with the safe-t-centesis drainage tray.The pa stated that when the needle was inserted, no ascitic fluid comes out through the catheter system; however, once the catheter system was removed from the needle, ascitic fluid was observed to flow.

• Brand Name: SAFE-T-CENTESIS TRAY 6FR X 16CM
• Common Device Name: Thoracentesis Tray
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): Bard Reynosa S.A. de C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas OK 88780 ; MX 88780
• Manufacturer Contact: brett curtice_ ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 25662094
• Report Number: 1423507-2026-00094
• Device Sequence Number: 21434224
• Product Code: PXI
• UDI-Device Identifier: 10885403108365
• UDI-Public: (01)10885403108365(17)280430(10)REKZ2033
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: PIG1260T
• Device Lot Number: REKZ2033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Supplement Date Received by Manufacturer: 09/19/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown