MAUDE Adverse Event Report: CARDINAL HEALTH TROCAR CATH 28FR

Model Number	8888561068
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.The customer has stated that the device will not be returned but has not provided rationale.
Event or Problem Description
Customer reports: a piece of pvc (from the (b)(6)) was still in the catheter and got lost in the patients' body.Fortunately, the part that detached was the piece with the x-ray line on it so they were able to detect and remove it afterwards.The piece was found close to the patients' ribs.There was no immediate patient harm, however, there were several extra-steps necessary.The catheter had to be changed and replaced and the patient was under anesthesia for an extended time period while removing this part.The patient as well as the legal department at the hospital were informed about this case.They tried to document this incident via photos.The sales representative has an appointment with the chief surgeon next week to discuss further steps at which time, photographs are expected to be provided to the sales representative.
Additional Manufacturer Narrative
Additional information provided therefore the following section has been updated after submission of the initial 3500a: section b3 - describe event or problem has been updated with additional information provided after the initial report.Investigation details: the device was received for evaluation and the reported condition has been confirmed.  a corrective and preventive action has been initiated to address the reported issue.
Event or Problem Description
On (b)(6) 2022 additional information provided stated that the surgery took approximately 15 minutes longer because of the issue so the patient was sedated for an additional 15 minutes.The patient has not experienced any complications thus far and no injury is reported.
Additional Manufacturer Narrative
The device was not received for evaluation however photographic evidence was provided and the reported condition has been confirmed.  a corrective and preventive action has been initiated to address the reported issue.Updated narrative: initially it was stated that the device was returned.

• Brand Name: TROCAR CATH 28FR
• Common Device Name: TROCAR
• Manufacturer (Section D): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13403775
• Report Number: 9611018-2022-00548
• Device Sequence Number: 5893148
• Product Code: DRC
• UDI-Device Identifier: 10884521029309
• UDI-Public: 10884521029309
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8888561068
• Device Catalogue Number: 8888561068
• Device Lot Number: 21K149FHX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/28/2022
• Supplement Date Received by Manufacturer: 01/28/2022; 01/28/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 03/04/2022; 03/11/2022
• 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: Required Intervention
• Patient Sex: Unknown