MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, KIT, 14.5F

Model Number 5834190

Device Problems Fluid/Blood Leak (1250); Material Separation (1562); Failure to Infuse (2340); Obstruction of Flow (2423); Improper Flow or Infusion (2954)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not 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.

Event Description

It was reported that post port device implant, the device allegedly experienced improper flow, infusion problem, material separation and leak.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a lot history review, device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Therefore, the reported improper flow, infusion problem, material separation and leak issue cannot be confirmed.A definitive root cause could not be determined.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.Section a through f ¿ the information provide 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.

Event Description

It was reported that post procedure, the device allegedly experienced improper flow, infusion problem, material separation and leak.The current status of the patient is unknown.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, KIT, 14.5F
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11085796
• MDR Text Key: 224419528
• Report Number: 3006260740-2020-21125
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013430
• UDI-Public: (01)00801741013430
• Combination Product (y/n): N
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5834190
• Device Catalogue Number: 5834190
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention