MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DL SHORT TERM DIALYSIS CATHETER KIT 15CM STRAIGHT; BLOOD ACCESS DEVICE AND ACCESSORIES

Catalog Number	5625150
Health Effect - Clinical Code	Coagulation Disorder (1779)
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, at this time, for evaluation.A lot history review (lhr) of reay1432 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation at this time.
Event or Problem Description
Facility reported to the sales representative that when the product was inserted, it appeared to be stiff but became soft and flimsy during insertion which created difficulty with placement.This caused clotting in using this device.No additional information has been provided at this time.No patient injury reported.

• Brand Name: DL SHORT TERM DIALYSIS CATHETER KIT 15CM STRAIGHT
• 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: 6341395
• Report Number: 3006260740-2017-00113
• Device Sequence Number: 1564018
• Product Code: MPB
• UDI-Device Identifier: 00801741042096
• UDI-Public: (01)00801741042096(17)180531(10)REAY1432
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K030268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2017

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: 05/31/2018
• Device Catalogue Number: 5625150
• Device Lot Number: REAY1432
• 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: 02/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1