MAUDE Adverse Event Report: CAREFUSION, INC TRAY CATH PARA THORA N-VLV SFR; NEEDLE, CATHETER

Model Number	OTP5000SP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (b)(4): initial emdr submission.A device was to be returned but not provided to date.A follow up emdr will be submitted if additional information becomes available.
Event or Problem Description
Material no: otp5000sp.Batch no: unknown.  it was reported that catheter broke off its base while removing catheter from patient as we normally remove when completing procedure.  verbatim: on two separate occasions catheter broke off its base while removing catheter from patient as we normally remove when completing procedure.The first occasion i witnesses this happen while the radiologist was performing the procedure.The second incident the catheter broke off while i was completing the procedure.
Additional Manufacturer Narrative
(b)(4): no sample was returned for analysis.Consequently, the investigation was not able to further evaluate the reported failure mode through a complaint sample analysis.A device history review could not be completed as no batch number was provided.Without a sample, photograph or lot information the investigation was unable to confirm the failure mode nor identify a probable root cause.As the failure mode was unable to be confirmed nor a root cause able to be determined a corrective and/or preventive action could not be identified for this complaint.This complaint will be entered into the complaint management system and will be tracked and trended for future occurrences.H3 other text: see narrative.
Event or Problem Description
Material no: otp5000sp; batch no: unknown.It was reported that catheter broke off its base while removing catheter from patient as we normally remove when completing procedure.  verbatim: on two separate occasions catheter broke off its base while removing catheter from patient as we normally remove when completing procedure.The first occasion i witnesses this happen while the radiologist was performing the procedure.The second incident the catheter broke off while i was completing the procedure.

• Brand Name: TRAY CATH PARA THORA N-VLV SFR
• Common Device Name: NEEDLE, CATHETER
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 11143441
• Report Number: 1625685-2021-00001
• Device Sequence Number: 16301314
• Product Code: PXI
• UDI-Device Identifier: 10885403470820
• UDI-Public: (01)10885403470820
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

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 Model Number: OTP5000SP
• Device Catalogue Number: OTP5000SP
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/24/2020
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 06/23/2021
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1