MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BROVIAC 4.2 FR CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF TISSUE INGROWTH; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 0600520

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2018

Event Type  malfunction  

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of huaw0287 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the facility that the patient was brought to the emergency department for a broviac line repair.The parent flushed the line and noticed ballooning in the catheter clamping area.The line was repaired.Line was placed approximately 10 months ago.No patient injury reported.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, frequency 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 ballooning during flushing is confirmed, and the cause is determined to be use-related.The device returned was found to be a segment of an extension leg and main tubing of a broviac 4.2 fr single lumen catheter.Visual observation found that the printing on the extension leg was largely faded and residues were found on the device, particularly the clamp; these are signs of extended use.Tactual evaluation found that the clamping sleeve manifested some tensile weakness and various impressions or clamping marks.Functional testing found that ballooning in the clamping sleeve occurred during infusion.The infusate did not immediately drain from the aneurysm when infusion was stopped.Massaging the catheter eliminated the aneurysm.This is typical of a break within inner tubing, causing redirection of flow into the clamping sleeve.Microscopic evaluation found a transverse hole at the point the internal portion of the luer adaptor terminated within the innermost tubing.The edges of this hole were rough a second hole was found in the innermost tubing on the same side, with several branches and much straighter edges.Examining the outer surface of the middle tubing found a longitudinal hole corresponding to the roughened hole and a straight-edged branched hole corresponding to the other.The damage appears to have been caused by contact of the internal portion of the luer adaptor against the inner tubing.This can occur when the device is clamped too near the luer adaptor, resulting in compression of the catheter between the internal portion of the luer adaptor and the clamp.This may also occur when the catheter is manipulated such that the luer adaptor stem rubs or pushes against the inner tubing.The complaint is determined to be use-related.The ifu states: ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smoothedged atraumatic clamps or forceps.¿ ¿clamping the catheter selection of the catheter clamp is very important since the catheter is vital to your care.The wrong clamp can damage the catheter.Follow these three rules for clamping: use only smooth-edged clamps.Always clamp the catheter over the reinforced clamping sleeve or tape tab, as instructed by your nurse.Never clamp over the reinforced segment directly adjacent to the connector.(see diagram) follow the directions of your doctor or nurse regarding when to clamp.Most hickman* and broviac* catheters come with pre-attached clamps and reinforced clamping sleeves.¿ a lot history review (lhr) of huaw0287 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the facility that the patient was brought to the emergency department for a broviac line repair.The parent flushed the line and noticed ballooning in the catheter clamping area.The line was repaired.Line was placed approximately 10 months ago.No patient injury reported.

• Brand Name: BROVIAC 4.2 FR CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF TISSUE INGROWTH
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 7289169
• MDR Text Key: 100908700
• Report Number: 3006260740-2018-00247
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051807
• UDI-Public: (01)00801741051807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0600520
• Device Catalogue Number: 0600520
• Device Lot Number: HUAW0287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 3 YR