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	07/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of safe t centesis tray, the app connected the tubing to the catheter and turns it on the system however, fluid backed up instead of flowing as intended.During follow-up response received on (b)(6)2026, it was reported that the issue was observed on two separate occasions after fluid had been aspirated into a syringe for laboratory testing and the system was connected to a gravity drain.At that time, a hissing sound indicating air escape was heard when connected to the vacuum bottle.Fluid was observed moving back toward the patient through the tubing; however, the user stopped the three-way stopcock before all of the fluid could return.No visible blockage, kinks, clamps, or obstructions were identified, and no damage was observed on the catheter, tubing, connectors.The procedure was being performed using a 6fr safe-t-centesis catheter, and all connections were reported to be secure and properly assembled.The issue was not resolved by replacing any components; instead, water was added to the white hub to create a water seal and address a potential air leak.No medical intervention, treatment delay, or patient harm was reported, although the issue required the clinician to spend additional time in the procedure room, impacting workflow and limiting the number of procedures that could be performed that day.During additional follow up response received on (b)(6)2026 it was further reported that the procedure was a thoracentesis performed using a 6fr safe-t-centesis kit.The reporter indicated that the issue occurred during two separate procedures involving different patients and the same lot number and same type of device were used for both occasions, although the event dates are not recalled.After approximately 200 cc of fluid was aspirated for laboratory testing, a gravity drainage bag was connected.At that time, fluid was observed moving toward the patient rather than toward the drainage bag.The reporter indicated that fluid was present in the tubing because it had been aspirated into a syringe for laboratory collection.A hissing sound suggestive of air escape was heard when the system was connected to the vacuum bottle.To address a possible air leak, sterile normal saline was dripped into the white hub on the catheter, where the stylet is removed, prior to stylet removal, creating a water seal.An app is an advanced practice provider.
Additional Manufacturer Narrative
H11: this supplemental mdr is being submitted to correct the g1: manufacturing location from mannford to reynosa.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 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: 50349876
• Report Number: 1423507-2026-00127
• Device Sequence Number: 20369752
• 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
• Was Device Available for Evaluation?: No
• 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: Not provided
• 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