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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNKNOWN PORT; IMPLANTABLE PORT
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BARD ACCESS SYSTEMS UNKNOWN PORT; IMPLANTABLE PORT Back to Search Results
Catalog Number UNK PORT
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Erythema (1840); Necrosis (1971); Skin Erosion (2075)
Event Type  Injury  
Manufacturer Narrative
Photos were provided for review.The lot number for the device was not provided, therefore, the device history records could not be reviewed.The device was not returned to the manufacturer for evaluation.The investigation is currently under way.(b)(4).
 
Event Description
It was reported that some time post port device implant, there was alleged redness over the site and port erosion over the septum.It was further reported that patient was hospitalized and the port device was removed with the tip missing.Reportedly, upon removal the port device was cultured, which was negative for infection.The patient status is stable post port device removal and is scheduled to be discharged.
 
Manufacturer Narrative
Manufacturing review: neither a lot history review nor a dhr review could be performed as the lot number was not provided.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: a sample evaluation could not be performed as the samples were not returned.However, five (5) electronic photos were reviewed.The first photo shows the port inside a clear plastic container with blood and residue throughout.The bard logo and other identifiers can be seen on the port.The second photo shows a different view of the port inside the container, flesh can be noted near the suture plugs of the port.The catheter seems to have a diagonal cut at the end near the 15 cm marker.The third photo shows another view of the port inside the container.The cathlock is seen still attached to the port and no visible access point can be seen on the septum.Blood and residue are noted throughout the sample.The fourth photo shows a better look at the tip of the catheter inside the container.Blood is noted inside the catheter, as well as a diagonal irregular shape.The fifth photo shows the chest of the patient which had the port removed from it.The erosion of the skin is notable at the site of implantation.The alleged erosion of the skin is confirmed.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.
 
Event Description
It was reported that some time post port device implant, there was alleged redness over the site and port erosion over the septum.It was further reported that patient was hospitalized and the port device was removed with the tip missing.Reportedly, upon removal the port device was cultured, which was negative for infection.The patient status is stable post port device removal and is scheduled to be discharged.
 
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Brand Name
UNKNOWN PORT
Type of Device
IMPLANTABLE PORT
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8916651
MDR Text Key155073659
Report Number3006260740-2019-02422
Device Sequence Number1
Product Code LJT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 11/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK PORT
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/25/2019
Initial Date FDA Received08/21/2019
Supplement Dates Manufacturer Received11/21/2019
Supplement Dates FDA Received11/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age4 YR
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