MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER PORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 4808061

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 07/17/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records 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 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.

Event Description

It was reported that some time post port implant, the patient allegedly developed hematoma over the surgical site.The current patient status is unknown.

Event Description

It was reported that some times post port implant, the patient allegedly developed hematoma over the surgical site.The current patient status is unknown.

Manufacturer Narrative

H10: manufacturing review: a lot history review, a device history record review, and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Therefore, the reported hematoma issue cannot be confirmed.A definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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: POWER PORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10384142
• MDR Text Key: 202171054
• Report Number: 3006260740-2020-02874
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027338
• UDI-Public: (01)00801741027338
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4808061
• Device Catalogue Number: 4808061
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other