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

Catalog Number	PIG1260T
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction

• 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: michael gaffney ; 75 n. fairview drive; vernon hills, IL 60061 ; +1(801)565-2341
• MDR Report Key: 50349399
• Report Number: 1423507-2026-00128
• Device Sequence Number: 14962284
• Product Code: PXI
• UDI-Device Identifier: 10885403108365
• UDI-Public: (01)10885403108365(17)280731(10)RELQ3350
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 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: RELQ3350
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/19/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown