MAUDE Adverse Event Report: CAREFUSION, INC SAFE-T PLUS THORACENTESIS/PARACENTESIS; THORACENTESIS TRAY

Catalog Number	TPT1000SP
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a1801.Patient problem code: f26.H10: d4 expiration date: 03/2026.H11: 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 customer that there was debris in one of the test tubes in the kit.Verbatim: rcc received a complaint via email.Noticed that there was debris in one of the test tubes in the kit.What was the original intended procedure? : paracentesis.Product number - tpt1000sp.Customer response on nov 11, 2024.1.Could you please provide a further description of the debris? no additional information provided.2.When was this defect observed? during or before use? after completing procedure.3.What was the impact to the patient? none.4.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No.5.Can you please provide an exact date of event in format dd-mmm-yyyy? 08-19-2024.6.Can you please provide the lot number associated with reported issue?0001569804.7.Any sample or photo available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? no.
Event or Problem Description
It was reported by customer that there was debris in one of the test tubes in the kit.Verbatim: rcc received a complaint via email.Email(s) attached noticed that there was debris in one of the test tubes in the kit.What was the original intended procedure? : paracentesis.Product number - tpt1000sp customer response on nov 11, 2024 1.Could you please provide a further description of the debris? no additional information provided.2.When was this defect observed? during or before use? after completing procedure.3.What was the impact to the patient? none 4.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No.5.Can you please provide an exact date of event in format dd-mmm-yyyy? 08-19-2024 6.Can you please provide the lot number associated with reported issue?0001569804 7.Any sample or photo available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? no.
Additional Manufacturer Narrative
H10: pr 11060125 follow-up emdr for device evaluation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001569804 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.Based on the available information we are not able to identify a root cause at this time.In an effort to raise awareness, a notification was sent to the supplier.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H11: 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 PLUS THORACENTESIS/PARACENTESIS
• 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: 20708380
• Report Number: 1625685-2024-00125
• Device Sequence Number: 8051639
• Product Code: PXI
• UDI-Device Identifier: 10885403108433
• UDI-Public: (01)10885403108433(11)240522(10)0001569804
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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: 03/31/2026
• Device Catalogue Number: TPT1000SP
• Device Lot Number: 0001569804
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown