MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATH 19CM ST EX KIT; DIALYSIS CATHETER

Model Number	5397190
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number of the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date: 07/2020).
Event or Problem Description
It was reported that a tunneler allegedly broke during dialysis catheter placement.Patient status is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: 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: one 19cm glidepath catheter and one tunneler was returned for evaluation.Visual and microscopic evaluations were performed.The investigation is confirmed for damaged/defective tunneler, as a break was noted on connecter of tunneler.The exact root cause for the damaged tunneler could not be determined.However, it is likely that supplier issues may have contributed to reported event.Labeling review: as this complaint has been found to be manufacturing/supplier related, a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) is not applicable.Product labeling would not have prevented this issue.H10: d4 (expiry date: 07/2020); h4 h11: h2, h3, h6 (results, conclusion), h7 h11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that a tunneler allegedly broke during dialysis catheter placement.Patient status is unknown.

• Brand Name: GLIDEPATH 19CM 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: 8620695
• Report Number: 3006260740-2019-01423
• Device Sequence Number: 10837343
• Product Code: MSD
• UDI-Device Identifier: 00801741012297
• UDI-Public: (01)00801741012297
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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 Expiration Date: 07/31/2020
• Device Model Number: 5397190
• Device Catalogue Number: 5397190
• Device Lot Number: RECZ1125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1