MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER TRIPLE LUMEN ACUTE DIALYSIS KIT, CURVED, 20CM; CATHETER, HEMODIALYSIS, TRIPLE-LUMEN, NON IMPLANTED

Catalog Number	5613200
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 following were reviewed as part of this investigation: patient severity, trend 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 guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was one j-tip guidewire.Blood residue was evident at both ends of the guidewire.Both inner core wires were broken and the outer coil wire was elongated near the proximal end.Both weld tips were intact.Tactile inspection revealed that the wire was extensible, confirming that both inner core wires were broken.Microscopic inspection of the sample revealed that both inner core wire breaks had occurred at the proximal weld tip.Material necking was evident in the vicinities of both breaks.Inspection of the break sites revealed dully granular surfaces.The break surfaces exhibited tapered profiles.Microscopic inspection of the weld tips revealed mechanical damage.The break features were typical of damage caused by tensile stress.The mechanical damage on the weld tips appeared consistent with contact between the wire and a hard metal object such as the introducer needle bevel.The blood residue at both ends of the guidewire indicated that the wire was inserted, removed, then the opposite end was inserted through the introducer needle.It appeared that during a second withdrawal attempt the wire became stuck.Subsequent pulling caused the observed break in the wire.The product ifu cautions ¿do not pull back guidewire over needle bevel as this may sever the end of the guidewire.The introducer needle must be removed first.Also, if unusual resistance is met during manipulation of the guidewire, discontinue the procedure and determine the cause of resistance before proceeding.Withdraw needle and guidewire if cause of resistance cannot be determined.¿ a lot history review (lhr) of rezj1040 showed no other similar product complaint(s) from these lot numbers.
Event or Problem Description
Is reported, that during the procedure, the guidewire "came flying out of the device", this took place while trying to feed and retract the guidewire.Returned sample has a broken core wire.

• Brand Name: POWER TRIPLE LUMEN ACUTE DIALYSIS KIT, CURVED, 20CM
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE-LUMEN, NON IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5430715
• Report Number: 3006260740-2016-00035
• Device Sequence Number: 16273532
• Product Code: NIE
• UDI-Device Identifier: 00801741041952
• UDI-Public: (01)00801741041952(17)190228(10)REZJ1040
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K083675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2015

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: 02/28/2019
• Device Catalogue Number: 5613200
• Device Lot Number: REZJ1040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2015
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2016
• Initial Report FDA Received Date: 02/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1