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

Model Number 5833730

Device Problems Material Opacification (1426); Stretched (1601); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation, however photos have been provided.The investigation of the reported event is currently underway.Expiry date (02/2021).(b)(4).

Event Description

It was reported that approximately three months post catheter placement, the catheter allegedly emulsified and deformed.It was further reported that device will be replaced.There was no reported patient injury.

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 device was not returned for evaluation.One electronic photo was received and reviewed.The photo shows the bifurcation, clamps, extension legs and part of the hubs of a hemostar catheter and the entry point at the skin.The catheter appeared to be sutured to the skin of the patient.Based on the photo review, opacification, stretching and protrusion in a segment of the extension leg (aneurysm) can be confirmed.However, the reported poor flow cannot be confirmed as there was no device was returned for sample evaluation.A definitive root cause could not be determined based upon 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 (expiry date: 02/2021),g4, h6 (device code:1248).H11: h6(result and conclusion).H11: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 Description

It was reported that approximately three months post catheter placement, the catheter allegedly emulsified and deformed.It was further reported that device will be replaced.There was no reported patient injury.

• 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
• MDR Report Key: 10074874
• MDR Text Key: 191588307
• Report Number: 3006260740-2020-01822
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013409
• UDI-Public: (01)00801741013409
• 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: 10/14/2020

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
• Device Operator: Health Professional
• Device Model Number: 5833730
• Device Catalogue Number: 5833730
• Device Lot Number: REDR2487
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/24/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 66