MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HGSTAR, 14.5 FR, ST, 23CM, STAND; DIALYSIS CATHETER

Model Number 5833730

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a review of the device history records could not be performed.Investigation summary: a sample evaluation could not be performed as the samples were not returned therefore the investigation is inconclusive for the alleged catheter migrated out issue due to the fact that no sample was returned for evaluation.A definitive root cause could not be determined.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.

Event Description

It was reported that during maintenance one month post catheter placement, the catheter allegedly migrated out; however, the cuff remained within the subcutaneous tunnel.It was further reported that medication was applied to the patient's skin.The cuff was removed under medical ultrasound (usg).No additional device was placed as infusion treatments were complete.There was no further reported patient injury post removal.

• Brand Name: HGSTAR, 14.5 FR, ST, 23CM, STAND
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9981415
• MDR Text Key: 188351291
• Report Number: 3006260740-2020-01445
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013409
• UDI-Public: (01)00801741013409
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5833730
• Device Catalogue Number: 5833730
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention