MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 19G X 0.75IN WITH Y-SITE; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0671934J
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2018
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that contrast medium allegedly flowed back through the sub route of the powerloc.Reportedly, during ct imaging with the powerport mri isp and the powerloc, when infusing contrast medium into the main rout of the powerloc, the medium allegedly flowed back from the sub route.Reportedly, prior to infusion, the operator exchanged the cap attached to the sub route for a non-pressure injection cap, connected a syringe, confirmed blood backflow, and flushed the catheter.There was no reported patient injury.

• Brand Name: POWERLOC SAFETY INFUSION SET 19G X 0.75IN WITH Y-SITE
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7602600
• Report Number: 3006260740-2018-01384
• Device Sequence Number: 16693062
• Product Code: LJT
• UDI-Device Identifier: 00801741151453
• UDI-Public: (01)00801741151453
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0671934J
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1