MAUDE Adverse Event Report: BARD ACCESS SYSTEMS RELIANCE XK ALPHACURVE LONG-TERM HEMODIALYSIS CATHETER W/AIRGUARD STANDARD KIT; HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS

Model Number	5325190
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2017
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 manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) of rebs0860 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that during placement "insertion of denovo tunneled central venous catheter for dialysis.The guidewire and the peel away sheath were defective in the kit.Another kit was used for the procedure.The reported event resulted in use of a new kit, causing an inconsequential prolongation of the procedure.No injury reported.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged airguard introducer was confirmed, but the exact cause of the damage was unknown.One 16.5fr airguard introducer sheath was returned for investigation.The dilator had been inserted and threaded onto the sheath.The protective tube that is attached to the airguard was not returned with the introducer.The white tabs were cracked apart along the score line.One side of the sheath was split apart 8mm distal to the white tabs.A microscopic examination revealed that the distal tip of the dilator was slightly out of round.Points of deformation were observed at the distal tip of the dilator, which is consistent with the wear pattern between the guidewire and dilator tip.Since the airguard introducer sheath and dilator had been assembled and locked together and since the dilator tip exhibited evidence of deformation, the damage most likely occurred during use; however, the exact mechanism of damage is unknown.A lot history review (lhr) of rebs0860 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that during placement "insertion of denovo tunneled central venous catheter for dialysis.The guidewire and the peel away sheath were defective in the kit.Another kit was used for the procedure.The reported event resulted in use of a new kit, causing an inconsequential prolongation of the procedure.No injury reported.

• Brand Name: RELIANCE XK ALPHACURVE LONG-TERM HEMODIALYSIS CATHETER W/AIRGUARD STANDARD KIT
• Common Device Name: HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6945852
• Report Number: 3006260740-2017-01829
• Device Sequence Number: 505935
• Product Code: MSD
• UDI-Device Identifier: 00801741012051
• UDI-Public: (01)00801741012051
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2017

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 Model Number: 5325190
• Device Catalogue Number: 5325190
• Device Lot Number: REBS0860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 83