MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HGSTAR, 14.5FR, ST, 19CM, STAND; DIALYSIS CATHETER

Model Number 5833690

Device Problems Device Damaged Prior to Use (2284); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 12/30/2019

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.(expiration date: 01/2021).

Event Description

It was reported that during preparation for a dialysis catheter placement, it was allegedly identified that the catheter's outer package was deformed.Reportedly, another device was used to complete the procedure.There was no patient contact.

Event Description

It was reported that during preparation for a dialysis catheter placement, it was allegedly identified that the catheter's outer package was deformed.Reportedly, another device was used to complete the procedure.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: although the sample was not returned for evaluation, two electronic photos were provided for review.The investigation is inconclusive for damage to packaging.Although packaging deformation was identified in the photos provided, the photos were originally reviewed in the investigation for complaint 1576750.As it could not be determined from the photos whether the packaging components were from two separate kits or from a single kit and the investigation for complaint 1575750 has been confirmed for packaging deformation, this investigation will remain inconclusive for damage to packaging.Although a definitive root cause could not be determined, excessive heat during shipping/storage could have potentially caused or contributed to the reported event.It is unknown whether patient and/or procedural factors contributed to the event.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: g4, h4.H11: d2, h6 (method, results, 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.

• Brand Name: HGSTAR, 14.5FR, ST, 19CM, STAND
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10435515
• MDR Text Key: 203806605
• Report Number: 3006260740-2020-03011
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013386
• UDI-Public: (01)00801741013386
• 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: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5833690
• Device Catalogue Number: 5833690
• Device Lot Number: REDQ4081
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 48