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

Catalog Number	OTP5000
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that when they opened the pack, it was a brown spot on the inside of the package.Verbatim: the item we have is cat.Otp5000, and when the pack was opened it was a brown spot on the inside of the package 1.Can you please provide the lot number associated with reported issue? lot number 0001555079 2.Any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? i do have the sample of the pack we can send.The sample is currently at our 1900 south ave.Location.If you email me a copy of the shipping label i can pack it and send it to where it needs to go.Bd rep response received on 16-aug-2024 1.Did the event directly, or indirectly involve a patient or user? if yes, what was the impact to the patient? no 2.Is there a photo available showing the reported issue for the evaluation? no.They are sending the product back.
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a1801.Patient problem code: f26.
Additional Manufacturer Narrative
Pr (b)(4) follow-up emdr for device evaluation: one tray sample was provided to our quality team for investigation.Through visual inspection, a small piece of corrugate debris was observed, on the outside of the wrap.It would have been enclosed within the sterile package; therefore, the reported failure mode was confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001555079 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.Awareness training has been performed with the assembly team to raise awareness.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.
Event or Problem Description
It was reported by customer that when they opened the pack, it was a brown spot on the inside of the package.Verbatim: the item we have is cat.Otp5000, and when the pack was opened it was a brown spot on the inside of the package.1.Can you please provide the lot number associated with reported issue? lot number 0001555079.2.Any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? i do have the sample of the pack we can send.The sample is currently at our 1900 south ave.Location.If you email me a copy of the shipping label i can pack it and send it to where it needs to go.Bd rep response received on 16-aug-2024.1.Did the event directly, or indirectly involve a patient or user? if yes, what was the impact to the patient? no.2.Is there a photo available showing the reported issue for the evaluation? no.They are sending the product back.

• 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: 20048044
• Report Number: 1625685-2024-00098
• Device Sequence Number: 7896075
• Product Code: PXI
• UDI-Device Identifier: 10885403284748
• UDI-Public: (01)10885403284748(11)240221(17)260731(10)0001555079
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/14/2024

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 Expiration Date: 07/31/2026
• Device Catalogue Number: OTP5000
• Device Lot Number: 0001555079
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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