MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT SINGLE LUMEN, TITANIUM WITH SILCONE OVERMOLD; IMPLANTABLE PORT

Model Number	1708062
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Erythema (1840); Pain (1994)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not 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 cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code (s) and provides general instruction 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 patient allegedly experienced swelling, discoloration and/or bruising of the port site after the port site was de-accessed.The health care provider discussed with the patient that the discoloration was leakage of body fluids underneath the skin.The patient was told to leave the area alone.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged port leak as no objective evidence has been provided to confirm any alleged deficiency with the port.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Possible contributing factors include use of coring needle, over pressurization, and splits/holes in septum seal; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).
Event or Problem Description
It was reported that the patient allegedly experienced swelling, discoloration and/or bruising of the port site after the port site was de-accessed.The health care provider discussed with the patient that the discoloration was leakage of body fluids underneath the skin.The patient was told to leave the area alone.There was no reported patient injury.

• Brand Name: POWERPORT SINGLE LUMEN, TITANIUM WITH SILCONE OVERMOLD
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7660908
• Report Number: 3006260740-2018-01614
• Device Sequence Number: 19424342
• Product Code: LJT
• UDI-Device Identifier: 00801741026645
• UDI-Public: (01)00801741026645
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K072549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2018

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: 1708062
• Device Catalogue Number: 1708062
• Device Lot Number: REYK1506
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 49