MAUDE Adverse Event Report: CAREFUSION, INC SAFE-T-CENTESIS; THORACENTESIS TRAY

Catalog Number	PIG1260T
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: 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.H3 (device eval by manufacturer) a device has not been returned.Upon completion of the investigation, a supplemental report will be filed.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 a hair was identified wrapped around one of the chloraprep swabs of the safe-t-centesis tray.
Additional Manufacturer Narrative
H11: the lot number was provided, so a device history record review was performed.A review of the internal manufacturing device record and raw material history files for the reported lot number was performed and no recorded quality problems or rejections related to this incident were found.It was confirmed that procedural and functional requirements needed for its release were met.A physical sample was not received by our quality team for evaluation.One photo was provided and reviewed.During photo review it was confirmed that there was a hair wrapped around the chloraprep product.However, we are unable to confirm the source of the hair.We are unable to confirm if the failure is manufacturing or supplier related.The supplier was notified of the failure to raise awareness.A definite root cause could not be determined.B5 (describe event or problem), g3 (date received by manufacturer), g6 type or report - follow up# 1), h2 (correction and additional information), h6: annex e (clinical code), annex f (impact code), annex g (component code), annex b (type of investigation), annex c (investigation findings), annex d (investigation conclusions).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 a hair was identified wrapped around one of the chloraprep swabs of the safe-t-centesis tray and that it is believed it was not used.Another kit was used to resolve the issue and treat the patient successfully.

• Brand Name: SAFE-T-CENTESIS
• 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: 22485401
• Report Number: 1625685-2025-00067
• Device Sequence Number: 12900188
• Product Code: PXI
• UDI-Device Identifier: 10885403108365
• UDI-Public: (01)10885403108365(17)251031(10)0001540142
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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: 10/31/2025
• Device Catalogue Number: PIG1260T
• Device Lot Number: 0001540142
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown