MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GLIDEPATH SLIM 10F LONG-TERM HEMODIALYSIS CATHTER, KIT, 15CM; DIALYSIS CATHETER

Model Number	5304150
Medical Device Problem Codes	Material Discolored (1170); Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.Expiration date: 10/2022.Device pending return.
Event or Problem Description
It was reported that sometime post dialysis catheter placement, the catheter allegedly cracked.It was further reported that, the device was removed.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that approximately six months post dialysis catheter placement, the catheter allegedly cracked.It was further reported that, the device was removed.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one 10f glidepath d/l catheter were returned for evaluation.Gross visual, tactile, microscopic and functional evaluations were performed.In addition to the returned physical sample, one electronic photo was also provided for review.The investigation is confirmed for the reported fracture and identified discoloration and deformation issue as fracture were noted on both strain reliefs and discoloration was noted throughout.Also twists were noted throughout the distal portion of the catheter body.A definitive root cause could not be determined based upon the available information.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 (expiration date: 10/2022), g3, h6 (device).H11: section a through f ¿ the information provided by bd represents all 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.

• Brand Name: GLIDEPATH SLIM 10F LONG-TERM HEMODIALYSIS CATHTER, KIT, 15CM
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16245229
• Report Number: 3006260740-2023-00130
• Device Sequence Number: 20434655
• Product Code: MSD
• UDI-Device Identifier: 00801741187308
• UDI-Public: (01)00801741187308
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K200627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2023

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: 5304150
• Device Catalogue Number: 5304150
• Device Lot Number: REEY0812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2022
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Sex: Male