MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ROVIAC CV CATHETER 2.7F SL, CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2017
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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leaking chronic catheter was confirmed and the cause appears to be use related.The product returned for evaluation was one 2.7fr s/l broviac catheter.The damage observed in the returned sample was characteristic of over-pressurization (burst) damage.This can occur through the use of syringes smaller than 10ml, by flushing against an occlusion, or due to excessive force applied during infusion procedures.The returned product sample was evaluated and a split was observed just distal of the intermediate tubing.This catheter damage was typical of a burst, and the characteristics observed which supported this type of failure included: 'c' shaped split.Tensile weakness at the fracture site (due to material ballooning prior to burst).Granular fracture surface texture (typical of tearing failure modes).The catheter material was visibly lighter in color at the fracture site.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.The product nursing guide provides the following guidance pertaining to occluded or partially occluded catheters: ¿to avoid catheter rupture, do not force entire amount into catheter if strong resistance is felt.¿ a lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by the facility that a crack was found in the catheter and it was subsequently removed in e.R.

• Brand Name: ROVIAC CV CATHETER 2.7F SL, CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6430247
• Report Number: 3006260740-2017-00304
• Device Sequence Number: 33878
• Product Code: LJS
• UDI-Device Identifier: 00801741036316
• UDI-Public: (01)00801741036316
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2017

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: N/A
• Device Catalogue Number: 0600044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2017
• Initial Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1