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

Catalog Number 0600540CE

Device Problems Break (1069); Fluid/Blood Leak (1250); Connection Problem (2900); Material Integrity Problem (2978)

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

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 be evaluated.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

(b)(6) 2015 broviac catheter allegedly broken near the hub and catheter connection.Reportedly placed on (b)(6) 2014 and said to have been repaired in (b)(6) 2015.No specific date reported.They alleged that the catheter most often breaks at the same place just below the hub at the "hard plastic piece" where the hub and the silicone catheter are assembled.They reportedly discovered the alleged breakage when giving heparin in the catheter for closing.The heparin allegedly leaked outside and thereafter the catheter was said to have been repaired with the appropriate repair kit.Parenteral nutrition was said to have been administered through the catheter.Facility has reported handling these catheters for more than 20 years and asked if the material for the hard plastic near the hub has changed because they stated they feel it has become more sharp.

• Brand Name: BROVIAC 6.6 FR SINGLE-LUMEN CV CATHETER
• 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): UNKNOWN; FR
• Manufacturer Contact: christy chandonia ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225631
• MDR Report Key: 5039719
• MDR Text Key: 25227458
• Report Number: 3006260740-2015-00382
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K830256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Report Date: 08/10/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 0600540CE
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Required Intervention