MAUDE Adverse Event Report: CAREFUSION, INC SAFE-T PLUS THORA/PARA 5FR NON-VALVED - OTP5000SP; THORACENTESIS TRAY

Model Number	OTP5000SP
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
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.(b)(4).
Event or Problem Description
It was reported that needle is leaking fluid.Per complaint details received: we are still having issues/ concerns with this product and leaking of fluid and the radiologist are requesting someone to come assist us and they prefer a valved needle that does not leak fluids before connecting to the tubing.It was also mentioned they are being exposed to bodily fluids.Per follow-up : this kit contains a "non valve catheter".There is no way to stop fluid from leaking from it.It is a safety risk to the patients and to the staff as we are being exposed to body fluid.It is not faulty, it is the wrong catheter for the procedure.The kit is adequate and will work fine if the catheter is changed out to a "valve" catheter.It is exactly the same size and style- but has a safety valve to keep the fluid from leaking out.
Event or Problem Description
It was reported that needle is leaking fluid.Per complaint details received: we are still having issues/ concerns with this product and leaking of fluid and the radiologist are requesting someone to come assist us and they prefer a valved needle that does not leak fluids before connecting to the tubing.It was also mentioned they are being exposed to bodily fluids.Per follow-up : this kit contains a "non valve catheter".There is no way to stop fluid from leaking from it.It is a safety risk to the patients and to the staff as we are being exposed to body fluid.It is not faulty, it is the wrong catheter for the procedure.The kit is adequate and will work fine if the catheter is changed out to a "valve" catheter.It is exactly the same size and style- but has a safety valve to keep the fluid from leaking out.
Additional Manufacturer Narrative
(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.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001421285 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.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: SAFE-T PLUS THORA/PARA 5FR NON-VALVED - OTP5000SP
• 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: 12536474
• Report Number: 1625685-2021-00065
• Device Sequence Number: 1337268
• Product Code: PXI
• UDI-Device Identifier: 10885403470820
• UDI-Public: (01)10885403470820
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2022

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: 05/31/2022
• Device Model Number: OTP5000SP
• Device Catalogue Number: OTP5000SP
• Device Lot Number: 0001421285
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 02/11/2022
• 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