MAUDE Adverse Event Report: CAREFUSION, INC SAFE-T-CENTESIS TRAY 8FR X 16CM; THORACENTESIS TRAY

Catalog Number	PIG1280T
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that after finding the needle obstructed, a new kit was utilized for a new needle.Patient had to experience a second abdomen puncture for the procedure to be completed.Additional event details reported in occurrence below.Verbatim: rcc received a complaint via email.Email(s) attached.Reported issue: patient was involved.After finding the needle obstructed, a new kit was utilized for a new needle.Patient had to experience a second abdomen puncture for the procedure to be completed.Additional event details reported in occurrence below.Affected tray has been kept to send in for investigation if desired by the manufacturer.
Additional Manufacturer Narrative
Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a140901.Patient problem code: f26.
Event or Problem Description
It was reported by customer that after finding the needle obstructed, a new kit was utilized for a new needle.Patient had to experience a second abdomen puncture for the procedure to be completed.Additional event details.Reported in occurrence below.Verbatim: rcc received a complaint via email.Email(s) attached.Are any samples available for return? yes.Reported issue: patient was involved.After finding the needle obstructed, a new kit was utilized for a new needle.Patient had to experience a second abdomen puncture for the procedure to be completed.Additional event details reported in occurrence below.Affected tray has been kept to send in for investigation if desired by the manufacturer, customer disposition request: credit.Additional information: occurrence date: 3/12/2024.Additional information: 1.Please provide differentiation between bio-hazard class a or class b? not familiar with this, please advise.2.What was the impact to the patient? extended procedure time and a second needle poke.3.How was the issue resolved? opened a new pig1280t tray.4.Was there any medical intervention required including diagnostics, procedures, and treatment delay? no.Secondary follow up on a quality complaint on product sold to our customer.Please respond accordingly with the rma number, if necessary, and the disposition of the concern.Please contact the customer and cc me on any future communication.The procedure took longer, we had to essentially poke the patient twice with a needle.And cost the rmc hospital a kit because we had to get a new one.
Additional Manufacturer Narrative
(b)(4).Follow-up emdr for device evaluation: one sample was provided to our quality team for investigation.The sample returned is class a biohazard.As per product complaint handling procedure if a category a substance is shipped to a bd facility, the sample will not be processed and will be destroyed per applicable regulations.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001531552 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.A quality notification has been sent to the supplier 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.

• Brand Name: SAFE-T-CENTESIS TRAY 8FR X 16CM
• 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: 19079702
• Report Number: 1625685-2024-00032
• Device Sequence Number: 5870388
• Product Code: PXI
• UDI-Device Identifier: 10885403108402
• UDI-Public: (01)10885403108402
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 08/16/2024

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: 08/31/2025
• Device Catalogue Number: PIG1280T
• Device Lot Number: 0001531552
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2023
• 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