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	08/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tray was being used on a patient and it broke.Verbatim: item otp5000 was being used on a patient and it broke.In the picture attached, i was told that the blue part broke off from the white part.There was no patient harm, but i wanted to report this for quality control.
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 tray was being used on a patient and it broke.Verbatim: item otp5000 was being used on a patient and it broke.In the picture attached, i was told that the blue part broke off from the white part.There was no patient harm, but i wanted to report this for quality control.
Additional Manufacturer Narrative
Pr (b)(4) follow-up emdr for device evaluation: one photo was received by our quality team for investigation.During visual inspection, the photos display the product label, confirming the reported product.There was no physical sample or photos provided that show any damage or defect with the product; therefore, the reported failure mode was not confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001458459 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.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.

• 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: 15254380
• Report Number: 1625685-2022-00080
• Device Sequence Number: 5807884
• Product Code: PXI
• UDI-Device Identifier: 10885403284748
• UDI-Public: (01)10885403284748
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

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: 12/31/2024
• Device Model Number: OTP5000
• Device Catalogue Number: OTP5000
• Device Lot Number: 0001458459
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 12/02/2022
• 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