MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 2.7F BROVIAC CV CATHETERS 0.5 MM LUMEN (WHITE ADAPTER) REPAIR KIT; INTRAVASCULAR CATHETER REPAIR KIT

Catalog Number	0601600
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/31/2016
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 for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of rexe1188 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On (b)(6) 2016 it was reported by facility that a patient had a broken catheter and was presented to the ed for repair.It was stated that the repair was attempted, site was stabilized, but the line continued to leak with gentle/small flushing and they were unable to draw blood despite repair.The patient was admitted for the administering of tpn and a new catheter was placed.No patient harm reported.

• Brand Name: 2.7F BROVIAC CV CATHETERS 0.5 MM LUMEN (WHITE ADAPTER) REPAIR KIT
• 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: 5949459
• Report Number: 3006260740-2016-00484
• Device Sequence Number: 671458
• Product Code: LJS
• UDI-Device Identifier: 00801741036378
• UDI-Public: (01)00801741036378(17)160630(10)REXE1188
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K830406
• 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): 08/23/2016

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: 06/30/2016
• Device Catalogue Number: 0601600
• Device Lot Number: REXE1188
• 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: 09/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 MO