MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4.5F MICROEZ UNIVERSAL PTFE MICROINTRODUCER SAFETY KIT; INTRODUCER, CATHETER

Model Number	N/A
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
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, at this time, to the manufacturer for evaluation.A lot history review (lhr) of rebw1338 showed no other similar product complaint(s) from this lot number.Device has not yet been returned for evaluation.
Event or Problem Description
It was reported by the facility that the line was placed some time in (b)(6) 2017 and a piece of the guidewire broke off during the procedure.It was stated the migrated section has not been removed from the patient.No other information as been provided.

• Brand Name: 4.5F MICROEZ UNIVERSAL PTFE MICROINTRODUCER SAFETY KIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7322488
• Report Number: 3006260740-2018-00397
• Device Sequence Number: 109909
• Product Code: DYB
• UDI-Device Identifier: 00801741038372
• UDI-Public: (01)00801741038372
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K915167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0678945
• Device Lot Number: REBW1338
• 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: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention