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

Catalog Number	OTP5000
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
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.Device problem code: a0201.Patient problem code: f26.
Event or Problem Description
It was reported by consumer that customer has opened 3 seperate otp5000 kits with product quality issues.Three instances involved: 1) uncapped needle.2) both lidocaines were broken off and empty.3) missing the yueh needle.Verbatim: rcc received a complaint via email.Email(s) attached.Customer has opened 3 seperate otp5000 kits with product quality issues.Three instances involved: 1) uncapped needle.2) both lidocaines were broken off and empty.3) missing the yueh needle.Had to throw 3 trays because of sterility concerns.Hcp had to open a new tray, 3 times.No impact to the patient.
Additional Manufacturer Narrative
Pr 9496526 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 possible lot number 0001484674 was performed and a non-conformance related to loose protector was identified.All procedural and functional requirements for product release have been met.Scar was issued to the supplier.Based on the available information we are not able to identify a root cause at this time as it's not clear which needle was missing its protector.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 consumer that customer has opened 3 separate otp5000 kits with product quality issues.Three instances involved: 1) uncapped needle 2) both lidocaines were broken off and empty 3) missing the yueh needle.Verbatim: rcc received a complaint via email.Email(s) attached.Customer has opened 3 seperate otp5000 kits with product quality issues.Three instances involved: 1) uncapped needle 2) both lidocaines were broken off and empty 3) missing the yueh needle.Had to throw 3 trays because of sterility concerns.Hcp had to open a new tray, 3 times.No impact to the patient.As per customer follow-up 01/23/2023 - was all three-issue reported is associated with the batch number# 0001484674? - no if not please provide lot numbers associated with specific failure.- no longer available was there a patient involvement? - no.What was the impact to the patient? no.Regarding uncapped needle issue - was the needle protector dethatched within the packaging? yes.Was the needle protector missing from the tray.

• 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: 18553354
• Report Number: 1625685-2024-00007
• Device Sequence Number: 12659171
• Product Code: PXI
• UDI-Device Identifier: 10885403284748
• UDI-Public: (01)10885403284748
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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: 10/31/2024
• Device Catalogue Number: OTP5000
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• 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