MAUDE Adverse Event Report: CAREFUSION, INC SAFE-T PLUS THORA/PARA 5FR NON-VALVED; THORACENTESIS TRAY

Catalog Number	OTP5000SP
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
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: a0501.Patient problem code: f24.
Event or Problem Description
It was reported by customer that i am reaching out to you in regards to an issue that 3 of our pulmonary critical care providers have brought to my attention involving the thora/para drainage trays (otp5000sp).They are having issues with the tube collapsing on itself which then requires them to obtain a 2nd kit to use in the middle of procedures.Verbatim: rcc received a complaint via email.Email(s) attached.I am reaching out to you in regards to an issue that 3 of our pulmonary critical care providers have brought to my attention involving the thora/para drainage trays (otp5000sp).They are having issues with the tube collapsing on itself which then requires them to obtain a 2nd kit to use in the middle of procedures.Have you heard any other complains or issues related to this?.
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.H3 other text : see manufacture narration.
Event or Problem Description
It was reported by customer that i am reaching out to you in regards to an issue that 3 of our pulmonary critical care providers have brought to my attention involving the thora/para drainage trays (otp5000sp).They are having issues with the tube collapsing on itself which then requires them to obtain a 2nd kit to use in the middle of procedures.Verbatim: rcc received a complaint via email.Email(s) attached.I am reaching out to you in regards to an issue that 3 of our pulmonary critical care providers have brought to my attention involving the thora/para drainage trays (otp5000sp).They are having issues with the tube collapsing on itself which then requires them to obtain a 2nd kit to use in the middle of procedures.Have you heard any other complains or issues related to this? follow-up: customer response on (b)(6) 2024 : 1.Can you please provide a exact date of event? i do not have exact dates.I just know it has occurred a few separate times with 3 different physicians reporting issues.2.Total number of events? (b)(4).3.Did the event directly, or indirectly involve a patient or user? if yes, what was the impact to the patient? yes, this occurred during procedures.It required them to obtain another kit to complete the procedure.4.Total number of patient involvement? 5.Was there any medical intervention required including diagnostics, procedures, and treatment delay? not necessarily that impacted the patient.6.How were bottles stored before use? in our supplies.7.Can you please provide the lot number associated with reported issue? no the packages were not saved and this was reported to me after the fact.8.Is there a photo or sample available showing the reported issue? if yes, are you able to provide the address of the facility for us to ship the return label? no unfortunately not.9.Did the tubing became disconnected during use at any junction? no.

• Brand Name: SAFE-T PLUS THORA/PARA 5FR NON-VALVED
• 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: 18712385
• Report Number: 1625685-2024-00019
• Device Sequence Number: 7255971
• Product Code: PXI
• UDI-Device Identifier: 10885403470820
• UDI-Public: (01)10885403470820
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/18/2024

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: OTP5000SP
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/18/2024
• 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