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	01/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the customer opened the otp5000 - 0001489094 where a scalpal was exposed.A sharp was exposed upon opening a kit.Rcc received a complaint via email.Email(s) attached.The customer opened the otp5000 - 0001489094 where a scalpal was exposed.A sharp was exposed upon opening a kit.Describe patient / (hcp) / user impact - no impact.As per follow-up: was the only scalpel was exposed? 1.Yes was there patient involvement? 2.No if yes, what was the impact to the patient/user? 3.No is there a photo or sample available showing the reported issue? if yes, please provide mailing address and email address.4.Sent to the rep unable to open attached photo.5.N/a what was done to resolve the issue.6.Tossed the tray because there was concern for sterility.
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a0201, patient problem code: f27.
Event or Problem Description
It was reported by the customer that the customer opened the (b)(4) where a scalpel was exposed.A sharp was exposed upon opening a kit.Rcc received a complaint via email.Email(s) attached.The customer opened the (b)(4) where a scalpel was exposed.A sharp was exposed upon opening a kit.Describe patient / (hcp) / user impact - no impact.As per follow-up: - was the only scalpel was exposed? 1.Yes - was there patient involvement? 2.No - if yes, what was the impact to the patient/user? 3.No - what was done to resolve the issue.6.Tossed the tray because there was concern for sterility.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one photo sample was received by our quality team for investigation.Upon visual inspection of the photo, it was observed that the scalpel is exposed; 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 0001489094 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 are unable to confirm a supplier failure, as we can't determine if damage occurred outside of supplier control.Although a supplier failure could not be definitively confirmed, we have sent a quality notification to raise awareness.In addition, awareness training was performed with incoming inspection and the assembly team.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: 18615493
• Report Number: 1625685-2024-00013
• Device Sequence Number: 12632168
• 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: Company Representative
• 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: 07/31/2024
• Device Catalogue Number: OTP5000
• Device Lot Number: 0001489094
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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