MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BROVIAC 4.2 FR CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF TISSUE INGROWTH; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number N/A

Device Problem Torn Material (3024)

Patient Problems Complaint, Ill-Defined (2331); Blood Loss (2597)

Event Date 03/31/2017

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) review is not possible; the manufacturing lot number that was provided is incorrect.

Event Description

It was reported by the facility that the patient was brought to the emergency department with a complete tear on the thin part of the distal extension on the broviac.The patient's mom heard him crying at 3:00 am and when she checked on him the sheet was wet with blood.The patient's mom clamped the line and brought him to the emergency department for repair.The line was repaired.

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, 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 a leak was confirmed, and the cause appears to be use related.The external segment of one 4.2 fr s/l broviac catheter was returned for investigation.The catheter extended 1.9 cm from the distal end of the clamping oversleeve.The cross section at the distal end of the catheter exhibited a glossy and striated surface, which is indicative of sharp instrument cut and is believed to be the location where the catheter was trimmed to make a repair.The printing on the clamping oversleeve was worn near the crimp collar.A longitudinal split was observed in the intermediate tubing just distal to the clamping oversleeve.The ends of the longitudinal split curved, giving the split a c-shape appearance.Under microscopic magnification, the split surfaces of the catheter were smooth and granular.The inner layer of 4.2fr catheter exhibited a c-shaped break in the tubing.The characteristics of the splits are consistent with a rupture due to over-pressurization.Functional testing revealed that the lumen was patent to infusion, but a leak was observed where the catheter was split.The section of tubing distal top the burst site was not returned for investigation.To help maintain catheter patency, flushing frequencies from once daily to once weekly have been found to be effective when the catheter is not in use.Flush with heparin after iv administration of total parenteral nutrition, iv fluids, or after medications.For frequently accessed catheters (accessed at least every 8 hours), flushing with 10 ml of sterile saline without heparin between infusions has been found to be effective.Caution: do not use a syringe smaller than 10 ml to flush or confirm patency.Small syringes can generate very high internal pressures with very little force.The back pressure from an occlusion may not be felt when using a small syringe until damage to the catheter has occurred.A thrombolytic solution may be used to declot the catheter if the lumen is occluded.A lot history review (lhr) review is not possible; the manufacturing lot number that was provided is incorrect.

Event Description

It was reported by the facility that the patient was brought to the emergency department with a complete tear on the thin part of the distal extension on the broviac.The patient's mom heard him crying at 3:00 am and when she checked on him the sheet was wet with blood.The patient's mom clamped the line and brought him to the emergency department for repair.The line was repaired.

• Brand Name: BROVIAC 4.2 FR CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF TISSUE INGROWTH
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6560728
• MDR Text Key: 75157904
• Report Number: 3006260740-2017-00596
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0600520
• Device Lot Number: HUAV_0291 (INCORRECT)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 11 MO