MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BROV 6.6FR S/L CATH & PIK; CHRONIC CATHETER

Model Number 0600540

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Local Reaction (2035)

Event Date 07/25/2018

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review 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.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 a pediatric patient allegedly developed a skin reaction to a chronic catheter approximately one year post insertion, which required medication administration.The health care provider reports the patient was tolerating the picc line at discharge without problems.

• Brand Name: BROV 6.6FR S/L CATH & PIK
• Type of Device: CHRONIC CATHETER
• 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.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7814532
• MDR Text Key: 241264121
• Report Number: 3006260740-2018-02234
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051821
• UDI-Public: (01)00801741051821
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 08/24/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: 0600540
• Device Catalogue Number: 0600540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 12 YR
• Patient Weight: 34