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 Ventricular Tachycardia (2132)

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 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

Sales rep reported that as the picc was being placed with the 3cg sherlock.The tip of the picc was placed in the cavo-atrial junction, causing the patient to go into v-tach.No other information was provided, but has been requested.On 8/7/2017, additional information reported by the facility.Picc placed (b)(6) 2017, at 11:45 am, per 3cg on the left side, 2cm.At 8:00pm patient went into v-tach, cardiac arrest for 1 minute.X-ray indicated infiltration right atrium, pulled back another 3 cm.On (b)(6) 2017, x-ray indicated upper right atrium, pulled back another 3cm.X-rays that were done on (b)(6) 2017, indicated correct placement.When x-ray was done on (b)(6) 2017, indicated infiltration, pulled back another 2cm.The final external length of 10cm, picc was removed on (b)(6) 2017, and discarded by the facility.No patient injury was reported.

• 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: 6817079
• MDR Text Key: 83507258
• Report Number: 3006260740-2017-01425
• 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,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Patient Outcome(s): Required Intervention