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

Model Number	1718501
Medical Device Problem Codes	Component Incompatible (1108); Material Frayed (1262)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2018
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 has been returned 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.
Event or Problem Description
It was reported that the hypo stuck on wire and will not move.Device was replaced.There was no patient injury reported.
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.This is the only complaint reported to date for this lot number and failure mode.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 guidewire and introducer needle from a ti lp powerport kit were returned for evaluation.The guidewire was received stuck in the introducer needle.Stretching was noted to the outer coil wire of the guidewire proximal to the introducer needle.When viewed under magnification, no damage was noted to the needle bevel, though blood and tissue residue could be seen on the guidewire in this region.Based on the findings, the investigation is confirmed for the reported guidewire advancement issue due to a frayed guidewire.The definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.Potential contributing factors include insertion technique and retraction against the introducer needle bevel.
Event or Problem Description
It was reported that the hypo was allegedly stuck on the wire and would not move.It was further reported that the device was replaced.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.This is the only complaint reported to date for this lot number and failure mode.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 guidewire and introducer needle from a ti lp powerport kit were returned for evaluation.The guidewire was received stuck in the introducer needle.Stretching was noted to the outer coil wire of the guidewire proximal to the introducer needle.When viewed under magnification, no damage was noted to the needle bevel, though blood and tissue residue could be seen on the guidewire in this region.Based on the findings, the investigation is confirmed for the reported guidewire advancement issue due to a frayed guidewire.The definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.Potential contributing factors include insertion technique and retraction against the introducer needle bevel.
Event or Problem Description
It was reported that during port device implant, the guide wire was allegedly stuck in the introduction needle and would not advance.It was further reported that the device was replaced.There was no reported patient injury.

• Brand Name: POWERPORT SLIM IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SINGLE-LUMEN VENOUS
• 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: 7523367
• Report Number: 3006260740-2018-00996
• Device Sequence Number: 19178778
• Product Code: LJT
• UDI-Device Identifier: 00801741026829
• UDI-Public: (01)00801741026829
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K081311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2019

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: 1718501
• Device Catalogue Number: 1718501
• Device Lot Number: REBY0757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 12/14/2018; 01/09/2019
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 01/08/2019; 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1