MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT MRI ISP, 8 FR GROSHONG, INTER. W SUTURE PLUG, S/L; IMPLANTABLE PORT

Model Number 1808560

Device Problem Break (1069)

Patient Problems Erythema (1840); Pain (1994); Skin Discoloration (2074); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Medical images have been made available to the manufacturer.Medical records were not provided.As the lot number for the device was provided, a review of the device history records will be performed.The device has not 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 Description

It was reported that the port catheter allegedly broke.It was further reported that the port catheter was removed and replaced by another port device.There was no reported patient injury.

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 investigation summary: the sample was not returned for evaluation.Four x-ray images were provided for review.Based on the image review, a catheter separation at the proximal segment near the port was confirmed.Therefore, the investigation is confirmed for the reported catheter break.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Potential contributing factors include over-pressurization, pinch off, chemical degradation and flexural fatigue.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.

Event Description

It was reported that the port catheter allegedly broke.It was further reported that the port catheter was removed and replaced by another port device.There was no reported patient injury.

Event Description

It was reported that the port catheter allegedly broke.It was further reported that the port catheter was removed and replaced by another port device.There was no reported patient injury.

Manufacturer Narrative

H10: 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: the sample was not returned for evaluation.Four x-ray images were provided for review.Based on the image review, a catheter separation at the proximal segment near the port was confirmed.Therefore, the investigation is confirmed for the reported catheter break.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Potential contributing factors include over-pressurization, pinch off, chemical degradation and flexural fatigue.H10: g4 h11: h6 (patient, method) h11:section a through f - the information provided by bd 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 bd.

• Brand Name: POWERPORT MRI ISP, 8 FR GROSHONG, INTER. W SUTURE PLUG, S/L
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7967618
• MDR Text Key: 123808498
• Report Number: 3006260740-2018-02903
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027116
• UDI-Public: (01)00801741027116
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1808560
• Device Catalogue Number: 1808560
• Device Lot Number: REYG0129
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5FU; 5FU; 5FU