MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GLIDEPATH 10F LONG-TERM DIALYSIS CATHETER, 12 CM; LONG- TERM HEMODIALYSIS CATHETER

Model Number	5303120
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record review is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 06/2022).
Event or Problem Description
It was reported that prior to the placement of dialysis catheter , the device allegedly had a labeling problem.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for the reported incorrect product length in the unit label based on the photo review.The definitive root cause has been identified as inadequate procedure and not following existing procedures during the label development process.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 06/2022), g3.H10: as the lot number for the device was not provided, a review of the device history record will not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that prior to a procedure, the device allegedly had a labeling problem.There was no patient contact.

• Brand Name: GLIDEPATH 10F LONG-TERM DIALYSIS CATHETER, 12 CM
• Common Device Name: LONG- TERM HEMODIALYSIS CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10703579
• Report Number: 3006260740-2020-20179
• Device Sequence Number: 19545361
• Product Code: MSD
• UDI-Device Identifier: 00801741187292
• UDI-Public: (01)00801741187292
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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: 5303120
• Device Catalogue Number: 5303120
• Device Lot Number: REEU2819
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other