MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARDPORT TITANIUM IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SINGLE-LUMEN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0602810
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Device not returned at this time.
Event or Problem Description
It was reported that the port was placed in the right internal jugular vein.Patient complained of pain and swelling during infusion.Ultrasound revealed a crack in the catheter with a contrast leak near the limb and insertion site.Device was removed in interventional radiology.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Investigation summary: one titanium port and 8 fr groshong catheter were returned for evaluation.Visual inspection identified a partial circumferential split between the 20 and 21 cm depth markers.The catheter split was typical of flexural fatigue, and characteristics observed which supported this type of failure included: a circumferentially aligned split and smooth and polished split edges.Therefore, the investigation is confirmed for flexural fatigue.The likely root cause of the identified flexural fatigue is use related.However, the definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.
Event or Problem Description
It was reported that the port was placed in the right internal jugular vein.Patient complained of pain and swelling during infusion.Ultrasound revealed a crack in the catheter with a contrast leak near the limb and insertion site.Device was removed in interventional radiology.There was no reported patient injury.

• Brand Name: BARDPORT TITANIUM IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SINGLE-LUMEN
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7770364
• Report Number: 3006260740-2018-02009
• Device Sequence Number: 2050483
• Product Code: LJT
• UDI-Device Identifier: 00801741025693
• UDI-Public: (01)00801741025693
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2018

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 Model Number: 0602810
• Device Catalogue Number: 0602810
• Device Lot Number: REWK0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 100