MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLINE 6FR TL; CHRONIC CATHETER

Model Number	0730610
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that a hole was allegedly discovered in the chronic catheter that caused a leak.It was further reported that the catheter was replaced the next day.There was no reported patient injury.
Event or Problem Description
It was reported that a hole was allegedly discovered in the chronic catheter that caused a leak.It was further reported that the catheter was replaced the next day.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one powerline 6.0 fr triple lumen polyurethane catheter was returned for evaluation.During infusion and aspiration testing, a leak was noted from a diagonal split in the powerline catheter approximately 1.2cm distal to the distal end of the junction hub.When viewed under magnification, it was noted that the split had a smooth surface.During testing, resistance was noted when attempting to infuse through the extension leg with the red hub.Based on the findings, the investigation is confirmed for the reported catheter leak.The definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.Potential contributing factors include over-pressurization, infusion against resistance and sharp instrument damage.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H11:section a through f - the information provided by bd 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 bd.

• Brand Name: POWERLINE 6FR TL
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8144323
• Report Number: 3006260740-2018-03543
• Device Sequence Number: 949818
• Product Code: LJS
• UDI-Device Identifier: 00801741036620
• UDI-Public: (01)00801741036620
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K093927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

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 Model Number: 0730610
• Device Catalogue Number: 0730610
• Device Lot Number: RECT0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 70