MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 12.5 FR TRIPLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUF; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 0600650

Device Problem Split (2537)

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

Event Date 03/23/2018

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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported by the physician that he had concerns that some of the 4.2 broviac catheters had split.Due to back orders of repair kits they were not able to repair them.No other information was provided.

• Brand Name: HICKMAN 12.5 FR TRIPLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUF
• 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): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: shauna nielson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225536
• MDR Report Key: 7426443
• MDR Text Key: 105511061
• Report Number: 3006260740-2018-00682
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051975
• UDI-Public: (01)00801741051975
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K830233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0600650
• Device Catalogue Number: 0600650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1