MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATH 42CM ST EX KIT; DIALYSIS CATHETER

Model Number	5397420
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 08/2020).
Event or Problem Description
It was reported that a dialysis catheter tunneler allegedly broke while placing the catheter.The procedure was able to be completed.There was no reported patient injury.
Event or Problem Description
It was reported that a dialysis catheter tunneler allegedly broke while placing the catheter.It was further reported that a plastic piece of the tunneler remained within the catheter lumen and was removed with clamps.The procedure was able to be completed without complication.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: a sample evaluation could not be performed as the samples were not returned therefore the investigation is inconclusive due to the fact that no sample was returned for evaluation.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Possible contributing factors include improper selection, improper dimensional design, effects of shipping and handling not accounted for; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.(expiry date: 08/2020); (results, conclusion).

• Brand Name: GLIDEPATH 42CM ST EX KIT
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8740368
• Report Number: 3006260740-2019-01781
• Device Sequence Number: 1330018
• Product Code: MSD
• UDI-Device Identifier: 00801741012341
• UDI-Public: (01)00801741012341
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

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: 5397420
• Device Catalogue Number: 5397420
• Device Lot Number: RECX1129
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1