MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BROVIAC 6.6 FR SINGLE-LUMEN CV CATHETER CUTDOWN TRAY WITH SURECUFF TISSUE; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	0600100
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2018
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 is pending return 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 surgeon attempted to flush the catheter prior to insertion and resistance was felt in the lumen and the catheter could not be flushed.The procedure was completed using a new device.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 6.6 fr s/l broviac catheter w surecuff was returned for evaluation.Functional, gross visual and microscopic visual, and tactile evaluations were performed.The investigation is inconclusive for failure to infuse, as it cannot be determined when the device was separated into multiple pieces and if sutures were present on the device at the time of the event.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, and contraindications) showed that the product labeling is adequate.
Event or Problem Description
It was reported that the surgeon attempted to flush the catheter prior to insertion and resistance was felt in the lumen and the catheter could not be flushed.The procedure was completed using a new device.There was no reported patient injury.

• Brand Name: BROVIAC 6.6 FR SINGLE-LUMEN CV CATHETER CUTDOWN TRAY WITH SURECUFF TISSUE
• 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: 7702849
• Report Number: 3006260740-2018-01760
• Device Sequence Number: 13679001
• Product Code: LJS
• UDI-Device Identifier: 00801741051708
• UDI-Public: (01)00801741051708
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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: 0600100
• Device Catalogue Number: 0600100
• Device Lot Number: HUAQ2352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1