MAUDE Adverse Event Report: BARD ACCESS SYSTEMS RED ADAPTER LEG FOR HICKMAN AND LEONARD MULTIPLE LUMEN CV CATHETERS; INTRAVASCULAR CATHETER REPAIR KIT

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2016
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) of reas2094 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
Facility contact reported that a dlhl 7fr line was placed on (b)(6) 2016.On (b)(6) 2016, a pinpoint hole was reportably noted at the hub of the red lumen.Line repair required.Patient will be followed on to see if line infection detected 7 days before or after line repair occurred.Will notify bard field assurance if line infection found.

• Brand Name: RED ADAPTER LEG FOR HICKMAN AND LEONARD MULTIPLE LUMEN CV CATHETERS
• Common Device Name: INTRAVASCULAR CATHETER REPAIR KIT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6247542
• Report Number: 3006260740-2016-00719
• Device Sequence Number: 994355
• Product Code: LJS
• UDI-Device Identifier: 00801741036422
• UDI-Public: (01)00801741036422(17)190528(10)REAS2094
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K830406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/21/2016

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: 05/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 0601690
• Device Lot Number: REAS2094
• 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: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1