MAUDE Adverse Event Report: CAREFUSION, INC THORACENTESIS/PARACENTESIS TRAY; THORACENTESIS TRAY

Catalog Number	TPT1000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during every procedure, the catheter used collapses.Verbatim: the customer reports that during every procedure, the catheter used collapses.Needing to know if components of the tray have changed.Requesting replacement.Distributor: medline.Primary contact will be out of town in 2 weeks from complaint submission.Requests for alternate contact dina to be contacted as well.Ref# (b)(4).Lot# not available at this time.
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: f24.H3 other text : see manufacture narration.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.Should you experience any problems with our product, examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.
Event or Problem Description
It was reported by the customer that during every procedure, the catheter used collapses.Verbatim: the customer reports that during every procedure, the catheter used collapses.Needing to know if components of the tray have changed.Requesting replacement.Distributor: medline.Primary contact will be out of town in 2 weeks from complaint submission.Requests for alternate contact dina to be contacted as well.

• Brand Name: THORACENTESIS/PARACENTESIS TRAY
• 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: 17745001
• Report Number: 1625685-2023-00090
• Device Sequence Number: 4160901
• Product Code: PXI
• UDI-Device Identifier: 10885403108488
• UDI-Public: (01)10885403108488
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/30/2023

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: TPT1000
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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