MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLINE 6FR D/L MI W/SCUFF; CHRONIC CATHETER

Model Number 0700615

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Burning Sensation (2146); Reaction (2414)

Event Date 10/30/2018

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will 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 the patient allegedly developed blisters, burning, and itching throughout the body post chronic catheter placement.It was further reported that the patient received medication for the symptoms and was hospitalized; however, the symptoms became worse and the patient was recommended to call her physician immediately.The patient status is unknown.

• Brand Name: POWERLINE 6FR D/L MI W/SCUFF
• 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: 8135585
• MDR Text Key: 129435186
• Report Number: 3006260740-2018-03480
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741036606
• UDI-Public: (01)00801741036606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/05/2018

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: 0700615
• Device Catalogue Number: 0700615
• Device Lot Number: RECV0208
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2018
• 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
• Patient Age: 54 YR
• Patient Weight: 81