MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 6.6F BROVIAC CV CATHETERS 1.0MM LUMEN (WHITE ADAPTER) REPAIR KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	0601620
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/15/2017
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not returned yet.
Event or Problem Description
It was reported that this repair kit was used in (b)(6) 2017.During infusion a leak was observed from between the catheter and the connecting sleeve.No patient harm reported.
Additional 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 a leak was confirmed, but how the catheter was damaged cannot be determined.One repair segment was received attached to a 2.5 cm segment of white tubing.The catheter had been cut 1.6cm from the distal end of the splice sleeve and the remainder of the catheter was not returned for investigation.Only one layer of tubing was visible distal to the repair site.Tape was wrapped around the section of tubing distal to the repair.A functional test revealed fluid leaking from a hole in the catheter at the distal end of the splice sleeve.No fluid leaked from the repair site.A microscopic examination of the leak site revealed a curved breach in the circumferential direction.A layer of adhesive was observed on the external surface of the catheter around the hole.A portion of the adjoining surfaces of the breached catheter exhibited a glossy surface.The remaining surface of the breached catheter exhibited a granular surface.The evidence of use suggests that the catheter was damaged while the catheter was implanted, but how the catheter was damaged could not be determined.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 that this repair kit was used in (b)(6) 2017.During infusion a leak was observed from between the catheter and the connecting sleeve.No patient harm reported.

• Brand Name: 6.6F BROVIAC CV CATHETERS 1.0MM LUMEN (WHITE ADAPTER) REPAIR KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7170077
• Report Number: 3006260740-2017-02386
• Device Sequence Number: 853642
• Product Code: LJS
• UDI-Device Identifier: 00801741074479
• UDI-Public: (01)00801741074479
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K830406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

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: 0601620
• Device Catalogue Number: 0601620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1