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

Model Number N/A

Device Problems Backflow (1064); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 04/18/2017

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) of huav0281 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the facility that the broviac ballooned when it was flushed.It was stated there was ballooning at the junction of the protective clamping sleeve and the catheter.It was noted by the nurse doing the repair that there were two previous repairs on the broviac.Previously there was not enough room to repair above the first repair, so a second repair was added and gi was notified.They also stated that there appeared to be blood in the outer catheter close to the insertion site.They stated the catheter did flush, but it was not able to draw blood, so they did not obtain cultures.The repair was placed in small griplock and dressing is covering the entire repair.The patient had the broviac replaced on (b)(6) 2017.

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 ballooning in the catheter was confirmed and the cause appeared to be use related.The product returned for evaluation was broviac repair catheter.The sample contained two regions of repair indicating it was at least the second repair for the original device.Gross visual evaluation confirmed blood and dressing residue indicating product use.Tactile evaluation revealed extreme tensile weakness in the catheter tubing just distal of the clamping oversleeve.The sample was patent to infusion using water and a 12ml syringe and no ballooning manifested during normal flow testing.Upon purposeful pressurization of the sample the catheter did balloon in the previously identified region of tensile weakness.During the pressurization a thinner region of catheter was observed in the balloon region.The state of the observed in the returned sample was characteristic of over-pressurization 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.Additionally, it is possible that the sample was accidentally pulled in this region which can also cause weakening of the catheter and manifest as material ballooning during infusion.

Event Description

It was reported by the facility that the broviac ballooned when it was flushed.They stated there was ballooning at the junction of the protective clamping sleeve and the catheter.It was noted by the nurse doing the repair that there were two previous repairs on the broviac.Previously there was not enough room to repair above the first repair, so a second repair was added and gi was notified.They also stated that there appears to be blood in the outer catheter close to the insertion site.They stated the catheter did flush, but it was not able to draw blood, so they did not obtain cultures.The repair was placed in small griplock and dressing is covering the entire repair.The patient is scheduled to have the broviac replaced on (b)(6) 2017.

• Brand Name: BROVIAC 4.2 FR SINGLE-LUMEN CV CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF
• 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6556724
• MDR Text Key: 74998796
• Report Number: 3006260740-2017-00588
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051807
• UDI-Public: (01)00801741051807(17)190728(10)HUAV0281
• 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,user faci
• Reporter Occupation: Other
• 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: 05/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 0600520
• Device Lot Number: HUAV0281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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: 11 MO