MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 6.6F BROVIAC CV CATHETERS 1.0MM LUMEN (WHITE ADAPTER) REPAIR KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	0601620
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
Event or Problem Description
It was reported that the facility has alleged the catheter has holes in the tubing, small splits in the tubing and/or separation at the repair kit.Device was removed.There was no 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.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.Investigation summary: one white hub hickman extension leg was returned for evaluation.Visual and microscopic inspection identified a partial circumferential break just distal to the white hub.Therefore, the investigation is confirmed for the alleged leak.The definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.
Event or Problem Description
It was reported that the catheter allegedly had holes in the tubing, small splits in the tubing, and/or separation in the repair kit.It was further reported that the device was removed.There was no patient injury.

• Brand Name: 6.6F BROVIAC CV CATHETERS 1.0MM LUMEN (WHITE ADAPTER) REPAIR KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7535522
• Report Number: 3006260740-2018-01042
• Device Sequence Number: 2018374
• Product Code: LJS
• UDI-Device Identifier: 00801741074479
• UDI-Public: (01)00801741074479
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K830406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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: 0601620
• Device Catalogue Number: 0601620
• Device Lot Number: REBS1935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 12/15/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 YR