MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 15 FR X 13 CM AIRGUARD VALVED INTRODUCER; INTRODUCER, CATHETER

Catalog Number	5513150
Health Effect - Clinical Code	No Information (3190)
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 reaw0641 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that this introducer has a clear plastic piece that is supposed to be attached to the white wing of the introducer.Facility reported that these two pieces were not attached and because of that the physician reported difficulty when introducing it into the internal jugular vein.

• Brand Name: 15 FR X 13 CM AIRGUARD VALVED INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6391663
• Report Number: 3006260740-2017-00213
• Device Sequence Number: 552736
• Product Code: DYB
• UDI-Device Identifier: 00801741041594
• UDI-Public: (01)00801741041594(17)180731(10)REAW0641
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2017

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: 07/31/2018
• Device Catalogue Number: 5513150
• Device Lot Number: REAW0641
• 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: 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1