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

Catalog Number	5593150
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2016
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 reyi0195 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
Health professional reported that during insertion of a sheldon in the right internal jugular vein, the guide ire became stuck in the jugular vein.Staff had difficulty removing the guidewire but were successful after 10 minutes of trying to remove.Patient had a venous compression but no hematoma.
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 stuck guidewire was confirmed and the cause appears to be use related.The product returned for evaluation was 0.038" x 70cm guidewire.The investigation findings are consistent with damage caused by retraction of the guidewire against the introducer needle.The returned product sample was evaluated and the guidewire was broken and the coil wire was unraveled.The damage region consisted of unraveled guidewire which began 1.6cm from the curvature of the ¿j¿ tip.It appeared that the inner core wire had broken which allowed the outer coil wire surrounding it to unravel.Biological material was seen on the wire which may have contributed to the observed guidewire fracture as retraction of the wire, together with the biological material, through the needle could have caused the pieces to become stuck.This was likely one of the main contributing factors to the event.Curling of the inner core wire was also seen which is characteristic of retraction against a sharp edged object (such as the needle bevel).Normal movement of the guidewire is away from the sharpened bevel and will not damage the wire.If the guidewire direction is reversed, the guidewire is then pulled against sharp edge of the needle bevel causing shearing damage.An examination of the wire structure revealed no potential damage/defect related to manufacture of the product.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM (SHORT-TERM) (DUAL-LUMEN)
• Common Device Name: NON-IMPLANTED BLOOD ACCESS DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5901444
• Report Number: 3006260740-2016-00453
• Device Sequence Number: 10922332
• Product Code: MPB
• UDI-Device Identifier: 00801741045561
• UDI-Public: (01)00801741045561(17)170828(10)REYI0195
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K030268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2016

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: 08/28/2017
• Device Catalogue Number: 5593150
• Device Lot Number: REYI0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2016
• Supplement Report FDA Received Date: 10/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1