MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 9 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF TI; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	0600604
Health Effect - Clinical Code	Chemical Exposure (2570)
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 for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of huap1493 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
Per sales representative, the facility reported that they went to draw blood for morning labs on a patient from a (b)(6).They were able to flush the first port without difficulty and drew specimens.They prepared the second port to flush and felt no resistance with the initial push and continued.Saline then sprayed out onto the patient¿s face.Facility noted a rupture in the catheter proximal to phalange prior to where the ports bifurcate.The line was clamped with hemostats, taped to the chest securely and the doctor notified.The catheter was replaced.Facility reported that it¿s possible that the clamp was positioned too low by the nurse on this patient¿s line.No patient injury reported.

• Brand Name: HICKMAN 9 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF TI
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6301293
• Report Number: 3006260740-2017-00039
• Device Sequence Number: 974977
• Product Code: LJS
• UDI-Device Identifier: 00801741051906
• UDI-Public: (01)00801741051906(17)200328(10)HUAP1493
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2017

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 Expiration Date: 03/28/2020
• Device Catalogue Number: 0600604
• Device Lot Number: HUAP1493
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1