MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNK S/L PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 3274118

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Sepsis (2067)

Event Type  Injury  

Manufacturer Narrative

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.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebu0324 showed two other similar product complaints from this lot number.

Event Description

It was reported that the picc was placed in (b)(6) 2017.The picc had to be removed due to the patient contracting sepsis as well as contact dermatitis.It was stated that the contact dermatitis is occurring only at the picc exit site and under the bifurcation.It is reported that the reaction develops slowly and intensifies over time.The site under the picc bifurcation is reported to be severely blistered, bubbling and flaking.They have trialed different dressings and have also omitted using different topical cleaning agents such as chlorahexidine per the direction of dermatology.They are currently only using a sterile telfa dressing changed every 48 hrs and the skin reaction and infections persist.Patient was treated with oral antibiotics and picc replacement in a new location.The patient recently had north american path testing-80 sample.It identified 4 chemicals that are commonly found in surgical adhesives, medical dressings, adhesives, medical plastics, sutures, wound care ointments.The picc is used for continuous hydration.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that the picc was placed in (b)(6) 2017.The picc required replacement due to contact dermatitis, excoriation and sepsis.The patient exhibited a red streak in the area of her picc, fever, and vital sign instability.Sepsis was treated in the hospital, but no specifics were provided.Contact dermatitis was said to have developed slowly and intensified over time.The site under the picc bifurcation is reported to be severely blistered, bubbling and flaking.The mother of the patient reports they have trialed various dressings, omitted topical cleaning agents, include chlorahexidine, as directed by a dermatologist.Currently, they are only able to use saline and alcohol to clean the site and sterile gauze, telfa and coban changed every 48 hours to dress it and the patient continues to experience the reaction.Patient also received oral antibiotics in an effort to treat the contact dermatitis.Mother states the reaction persists.The patient had a north american patch allergy testing of 80 samples, it identified 4 chemicals commonly found in surgical adhesives, medical dressings, medical plastics, sutures, and wound care ointments.

• Brand Name: UNK S/L PICC
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7445417
• MDR Text Key: 106009594
• Report Number: 3006260740-2018-00757
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741027840
• UDI-Public: (01)00801741027840
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3274118
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention