MAUDE Adverse Event Report: CARDINAL HEALTH TROCAR CATH 28FR

Model Number 8888561068

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/26/2022

Event Type  Injury  

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 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.

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 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.

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
• Type of Device: 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
• MDR Text Key: 284863666
• Report Number: 9611018-2022-00548
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 10884521029309
• UDI-Public: 10884521029309
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 01/28/2022; 01/28/2022
• Supplement Dates FDA Received: 03/04/2022; 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention