MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATH LONG-TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET EXCHANGE KIT (14; BLOOD ACCESS DEVICE AND ACCESSORIES

Catalog Number	5397310
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2016
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 to the manufacturer for evaluation.A lot history review (lhr) of reyk1021 showed no other similar product complaint(s) from these lot numbers.
Event or Problem Description
Per sales representative, facility reported that during placement, the catheter penetrated the mediastinum.Physician was able to pull the catheter back and used a wire to continue advancing the catheter for placement.No patient injury reported or additional medical intervention required.

• Brand Name: GLIDEPATH LONG-TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET EXCHANGE KIT (14
• Common Device Name: BLOOD ACCESS DEVICE AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5466279
• Report Number: 3006260740-2016-00065
• Device Sequence Number: 10810968
• Product Code: MSD
• UDI-Device Identifier: 00801741012327
• UDI-Public: (01)00801741012327(17)161028(10)REYK1021
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2016

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 Expiration Date: 10/28/2016
• Device Catalogue Number: 5397310
• Device Lot Number: REYK1021
• 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: 02/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 90