MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM (PRE-CURVED) (SHORT-TERM) (DUAL-LUMEN; NON-IMPLANTED BLOOD ACCESS DEVICE

Catalog Number 5594150

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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.A lot history review (lhr) of rewl1259 showed no other similar product complaint(s) from this lot number.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 that the guidewire could not be inserted through the needle was confirmed, and the cause appears to be use related.One j-tipped guidewire and an 18g introducer needle from a niagara kit were returned for evaluation.The distal j-tip of the guidewire was received inside the introducer needle.The guidewire could not be advanced or retracted through the introducer needle.A 7cm section of coil wire was stretched over the core wire just proximal to the pink needle hub.It was possible to stretch the coil wire over the core wire.Upon forcing the guidewire from the needle, blood residue was found on the section of coil wire that was within the introducer needle.Blood and/or tissue residue was extracted from the needle.It appears that the needle was inadvertently lodged within the needle with a small amount of soft tissue.No defects related to the manufacturing procedure were noted on the complaint sample.The 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.¿.

Event Description

Facility reported to ibc via cir that the guidewire allegedly could not be inserted.Cir lists the date of event occuring in 2014.

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.This event was initially reported with an incorrect mdr date of awareness of 9/29/2015.However, the reportable malfunction was noted and confirmed by a bard access systems¿ engineer on 11/25/2015 during the sample evaluation.The correct mdr date of awareness is 11/25/2015.The additional information that required submission of an emdr was provided in the initial emdr submitted on 12/10/2015, within the 30 day time frame required for reporting per 21 cfr part 803.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM (PRE-CURVED) (SHORT-TERM) (DUAL-LUMEN
• Type of Device: NON-IMPLANTED BLOOD ACCESS DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: maren treft ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225964
• MDR Report Key: 5281900
• MDR Text Key: 33520528
• Report Number: 3006260740-2015-00570
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045608
• UDI-Public: (01)00801741045608(17)171229(10)REWL1259
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K090102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/06/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 12/29/2017
• Device Catalogue Number: 5594150
• Device Lot Number: REWL1259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1