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

Catalog Number	PIG1260T
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: there were no photos provided for review, but a physical sample was received by our quality team for evaluation.During evaluation, a partial tray was returned for analysis.One catheter was returned.The inner valve of the catheter was found damaged, creating an opening/hole, which could lead to a leak.Therefore, the result of the investigation confirmed the reported failure.A definite root cause and when the damaged occurred could not be determined.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001619203 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.Complaints received for this product and conditions will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for the identification of emerging trends.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 initially reported that the safe-t-centesis catheter drainage system did not function as intended during a diagnostic thoracentesis procedure.Initially, the customer stated that there were no injuries or adverse events associated with the complaint.During follow-up with the facility, it was clarified that the safe-t-centesis needle was introduced with positive fluid return, and the catheter was advanced.Upon initiating manual aspiration, air was unexpectedly aspirated from the catheter.The system only aspirated fluid when the white membrane area was manually occluded; otherwise, air entered the catheter, producing an audible hiss.Suction was completed while maintaining occlusion of the one-way membrane, and the catheter was removed.A follow-up chest x-ray revealed a loculated hydro-pneumothorax.The patient remained under supervision for additional imaging.

• 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): 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: 23501364
• Report Number: 1423507-2025-00138
• Device Sequence Number: 15668103
• Product Code: PXI
• UDI-Device Identifier: 10885403108365
• UDI-Public: (01)10885403108365(10)0001619203
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PIG1260T
• Device Lot Number: 0001619203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2025
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2025
• 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 Age: 67 YR
• Patient Sex: Male