MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 5F MICROEZ UNIVERSAL PTFE MICROINTRODUCER SAFETY KIT; CATHETER INTRODUCER

Catalog Number	0678950
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2016
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.A lot history review (lhr) of rear0577 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On 09/27/2016- per medwatch, the facility reported "attempted to place picc in right basilica vein, obtained access but unable to thread wire.While removing wire, resistance was met.Upon total removal of wire, noted to have unraveled and copper tip visualized.Order for right arm x-ray obtained." no patient injury reported.

• Brand Name: 5F MICROEZ UNIVERSAL PTFE MICROINTRODUCER SAFETY KIT
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6045415
• Report Number: 3006260740-2016-00554
• Device Sequence Number: 16156889
• Product Code: DYB
• UDI-Device Identifier: 00801741038389
• UDI-Public: (01)00801741038389(17)200328(10)REAR0577
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K915167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2016
• Report Date (Section F): 09/11/2016

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: 03/28/2020
• Device Catalogue Number: 0678950
• Device Lot Number: REAR0577
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/10/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/11/2016