MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET 14.5F; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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, at this time, for evaluation.A lot history review (lhr) of rezj0398 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (rezj0398) have been reported from the same (b)(6) facility.Device not yet returned for evaluation.
Event or Problem Description
It was reported that equistream was inserted (b)(6) 2016.It was stated that the venous clamp on the catheter broke.It was reported that the clamp had been in place for 9 months and broke at the base, no problems were noticed with engaging the clamp prior to the break.The catheter was accessed for infusion and aspiration 3 times a week.The catheter and dressing were cleaned every week with 2% w/v chlorhexidine gulconate and 70% v/v isopropyl alcohol.It was stated that the hospital procedure protocol for a dialysis catheter is to replace the clamp and complete an incident report.No patient harm was reported.

• Brand Name: EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET 14.5F
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6692321
• Report Number: 3006260740-2017-00982
• Device Sequence Number: 992892
• Product Code: MSD
• UDI-Device Identifier: 00801741013706
• UDI-Public: (01)00801741013706
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K090101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/07/2017

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: 07/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 5903230
• Device Lot Number: REZJ0398
• 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: 07/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1