MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 9 FR PEDIATRIC LENGTH DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	0600580
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.(b)(4).
Event or Problem Description
It was reported that when flushing the line, prior to blood draw, the lumen proximal to the bifurcation hub burst.The catheter was later removed and a new device was placed.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged lumen break as no objective evidence has been provided to confirm any alleged deficiency with the catheter.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Possible contributing factors include over pressurization and insufficient wall thickness; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.(b)(4).
Event or Problem Description
It was reported that when flushing the line, prior to blood draw, the lumen proximal to the bifurcation hub burst.The catheter was later removed and a new device was placed.There was no reported patient injury.

• Brand Name: HICKMAN 9 FR PEDIATRIC LENGTH DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER 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: 7648816
• Report Number: 3006260740-2018-01538
• Device Sequence Number: 11150755
• Product Code: LJS
• UDI-Device Identifier: 00801741051883
• UDI-Public: (01)00801741051883
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2018

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: 0600580
• Device Catalogue Number: 0600580
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1