MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATH 23CM ST EX KIT; DIALYSIS CATHETER

Model Number	5397230
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review was not required to be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 08/2021).
Event or Problem Description
It was reported that during dialysis catheter insertion, the catheter tip allegedly broke off during the tunneling process.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: as the lot number for the device was provided, a manufacturing review was not required to be performed.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.Investigation summary: a sample evaluation could not be performed as the samples were not returned therefore the investigation is inconclusive for the alleged catheter tip break during tunneling issue due to the fact that no sample was returned for evaluation.A definitive root cause could not be determined.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 during dialysis catheter insertion, the catheter tip allegedly broke off during the tunneling process.There was no reported patient injury.

• Brand Name: GLIDEPATH 23CM 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: 9845427
• Report Number: 3006260740-2020-00870
• Device Sequence Number: 19547062
• Product Code: MSD
• UDI-Device Identifier: 00801741012303
• UDI-Public: (01)00801741012303
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2020

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: 5397230
• Device Catalogue Number: 5397230
• Device Lot Number: REDW3611
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1