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

Model Number	PIG1280T
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that catheter is bending upon insertion.Verbatim: omit has come to me about the 8fr catheter that comes in the safet-centesis tray (ps 125640).The catheter has been bending when it is being inserted in the wall of the patient.This is a new issue, and has been noticed in the last 3-4 kits that we have used.When this catheter bends it is happening inside of the patient and causing the patient a great amount of discomfort.
Additional Manufacturer Narrative
(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
It was reported by the customer that catheter is bending upon insertion.Verbatim: omit has come to me about the 8fr catheter that comes in the safet-centesis tray ((b)(4)).The catheter has been bending when it is being inserted in the wall of the patient.This is a new issue, and has been noticed in the last 3-4 kits that we have used.When this catheter bends it is happening inside of the patient and causing the patient a great amount of discomfort.10nov2022: - what was the impact to the patient? the 8fr catheter was difficult to pass into the abdominal wall of the patient, even after using the 11-blade to make a small incision.On three particular occasions, the metal catheter actually bent before it passed into the patient.I suspect this is due to the needle tip not being sharp enough and then the metal (being a little flimsy) not being able to support the force.- how was the issue resolved? it was only three kits that i¿ve noticed so far.But for those three patients, a separate needle was utilized instead - was there a need to repeat the procedure? no - is there a photo or sample available showing the reported issue for the evaluation? the faulty catheter was discarded on each occasion.- were they able to complete the diagnosis correctly? no patient diagnosis was delayed.The patients just experienced more discomfort than they typically would.
Additional Manufacturer Narrative
(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 0001484822 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 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.

• 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: 15770687
• Report Number: 1625685-2022-00095
• Device Sequence Number: 12419797
• Product Code: PXI
• UDI-Device Identifier: 10885403108402
• UDI-Public: (01)10885403108402
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 01/27/2023

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: 10/31/2024
• Device Model Number: PIG1280T
• Device Catalogue Number: PIG1280T
• Device Lot Number: 0001484822
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 01/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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