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

Model Number	OTP5000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (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 by the customer that the lead broke off in the patient.Lead broke off inside the patient on (b)(6) 2022.Please follow up with (b)(6) for batch number, sample availability and any additional information.On (b)(6) 2022, please provide the full name and address of the facility for where the issue occurred.(b)(6).Can you provide the lot#? no.Was there any patient impact? was there any need for medical intervention? were there any x rays taken? no impact, the catheter was able to be removed from the patient without issues.Staff was able to grab the small section outside the body and remove with hemostats.Was the product retrieved from the patient? yes.Do you have any photos of the reported issue? no.Is the product available for evaluation? yes.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one sample was provided to our quality team for investigation.Through visual inspection, it was observed that catheter is detached from catheter hub; therefore, the reported failure could be verified.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.A quality notification sent to the vendor for awareness of the defect.Manufacturing personnel have been notified of this incident and awareness training was provided.Complaints received for this device and defect will continue to be monitored for future occurrences.
Event or Problem Description
It was reported by the customer that the lead broke off in the patient.Verbatim: lead broke off inside the patient on 08/31/2022.Please follow up with theresa for batch number, sample availability and any additional information.¿ please provide the full name and address of the facility for where the issue occurred.Mclaren oakland 50 n.Perry st., pontiac, mi 48342.¿ can you provide the lot#? no.¿ was there any patient impact? was there any need for medical intervention? were there any x rays taken? no impact, the catheter was able to be removed from the patient without issues.Staff was able to grab the small section outside the body and remove with hemostats.¿ was the product retrieved from the patient? yes.¿ do you have any photos of the reported issue? no.¿ is the product available for evaluation? yes.

• Brand Name: THORA/PARA TRAY, 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: 15537113
• Report Number: 1625685-2022-00087
• Device Sequence Number: 12304050
• Product Code: PXI
• UDI-Device Identifier: 10885403284748
• UDI-Public: (01)10885403284748
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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 Model Number: OTP5000
• Device Catalogue Number: OTP5000
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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