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

Catalog Number	TPT1000SP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
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: a0401.Patient problem code: f26.
Event or Problem Description
It was reported by customer that the introducer needle broke during the procedure.Verbatim: rcc received a complaint via email.Email(s) attached.The introducer needle broke during the procedure.They had to open another tray to complete the procedure.Describe patient / hcp / user impact - opened another tray to complete the procedure.
Event or Problem Description
It was reported by customer that the introducer needle broke during the procedure.Verbatim: rcc received a complaint via email.Email(s) attached.The introducer needle broke during the procedure.They had to open another tray to complete the procedure.Product number - tpt1000sp.Lot number - 00018559052.Describe patient / hcp / user impact - opened another tray to complete the procedure.
Additional Manufacturer Narrative
Pr (b)(4) 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, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.We would be very interested in examining product that does not meet your expectations and our quality standards.A photo of the defect could assist our quality team in their investigation.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis of the affected device.Examination of the product involved may provide clarification as to the cause for the reported failure.We regret any inconveniences this incident may have caused you and your facility.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

• 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: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 19771467
• Report Number: 1625685-2024-00081
• Device Sequence Number: 8110982
• Product Code: PXI
• UDI-Device Identifier: 10885403108433
• UDI-Public: (01)10885403108433
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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 Catalogue Number: TPT1000SP
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown