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

Catalog Number	OTP5000
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a041001.Patient problem code: (b)(6).
Event or Problem Description
It was reported by customer that hole found in sterile package after opening the package.Verbatim: it was reported, we have received a quality complaint on product sold to our customer.Please contact the customer and cc (b)(6) on any future communication.Injuries or adverse event: no.Item: otp5000.Quantity affected: 1 ea.Serial/lot number: (b)(6).Po : (b)(6).Are any samples available for return? yes.Reported issue: hole found in sterile package after opening the package.Original package obtained with no item in the package.There was the only one issue of a hole in the bag that was supposed to be sterile.I was just stating that i had the original package but i did not have the product that was in the package from the department that was reporting.That the item had a hole in it.
Additional Manufacturer Narrative
Pr(b)(4).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 lot number (b)(6) 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.Manufacturing personnel have been notified of this incident and awareness training was provided.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.H3 other text : see manufacture narration.
Event or Problem Description
It was reported by customer that hole found in sterile package after opening the package.Verbatim: it was reported, we have received a quality complaint on product sold to our customer.Please contact the customer and cc (b)(6) and (b)(6) on any future communication.Injuries or adverse event: no item: otp5000 quantity affected: 1 ea serial/lot number: (b)(6).Po : 4516205216 are any samples available for return? yes.Reported issue: hole found in sterile package after opening the package.Original package obtained with no item in the package.There was the only one issue of a hole in the bag that was supposed to be sterile.I was just stating that i had the original package but i did not have the product that was in the package from the department that was reporting.That the item had a hole in it.

• 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: 17397633
• Report Number: 1625685-2023-00072
• Device Sequence Number: 12676891
• Product Code: PXI
• UDI-Device Identifier: 10885403284748
• UDI-Public: (01)10885403284748
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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 Expiration Date: 07/31/2024
• Device Catalogue Number: OTP5000
• Device Lot Number: 0001482498
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• 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