MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNKNOWN PICC; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not returned at this time.

Event Description

It was reported by the sales rep that the facility reported six occurrences where they are positive pressure flushing and clamping the clamp and still being able to flush.They state that they have taken off the pinch clamp and added another manufacturer's slide clamp.This file addresses the third occurrence.

• Brand Name: UNKNOWN PICC
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR 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. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 7094678
• MDR Text Key: 94411594
• Report Number: 3006260740-2017-02207
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• 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