MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARDPORT TITANIUM IMPLANTABLE PORT WITH PRE-ATTACHED 6.6F OPEN-ENDED SINGLE-LUM; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0602280
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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.
Event or Problem Description
It was reported that the port is leaking into her body, due to an alleged crack discovered via x-ray.The port is scheduled to be removed.There was no reported patient injury.
Event or Problem Description
It was reported that the port is leaking into her body, due to an alleged crack discovered via x-ray.The port is scheduled to be removed.There was no reported patient injury.
Additional Manufacturer Narrative
A manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Received one titanium implantable port with one 6.6 fr s/l silicone catheter segment for evaluation.Tool damage was noted on the catheter body near the cath lock.The distal end of the received catheter was fractured due to sharp instrument damage.However, the investigation is inconclusive for the alleged leak as it is unknown if the catheter was trimmed to this length or if this fracture is the reported event.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.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date: 01/2023).

• Brand Name: BARDPORT TITANIUM IMPLANTABLE PORT WITH PRE-ATTACHED 6.6F OPEN-ENDED SINGLE-LUM
• 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: 7606969
• Report Number: 3006260740-2018-01415
• Device Sequence Number: 19272298
• Product Code: LJT
• UDI-Device Identifier: 00801741025600
• UDI-Public: (01)00801741025600
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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: 0602280
• Device Catalogue Number: 0602280
• Device Lot Number: RECN0081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 147