MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HGSTAR, 14.5 FR, ST, 35CM, STAND; DIALYSIS CATHETER

Model Number	5833350
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Photos were provided for review.As this is the only complaint associated with this lot number, a device history record review will not be required.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(b)(4), (expiration date: 12/2020).
Event or Problem Description
It was reported that upon opening the dialysis catheter package, foreign material was allegedly present and the catheter was not used.Reportedly, another catheter was opened to complete the procedure.There was no patient contact.
Additional Manufacturer Narrative
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.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.Investigation summary: one hemostar hemodialysis catheter photo was received and evaluated.The photo appears to show a whitish foreign material on the device package, this investigation confirms the alleged foreign material in device package.The definite root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Pma/510k mfr site (results, conclusion.).
Event or Problem Description
It was reported that upon opening the dialysis catheter package, foreign material was allegedly present and the catheter was not used.Reportedly, another catheter was opened to complete the procedure.There was no patient contact.

• Brand Name: HGSTAR, 14.5 FR, ST, 35CM, STAND
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8923246
• Report Number: 3006260740-2019-02473
• Device Sequence Number: 1904152
• Product Code: MSD
• UDI-Device Identifier: 00801741013362
• UDI-Public: (01)00801741013362
• Combination Product (Y/N): N
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

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: 5833350
• Device Catalogue Number: 5833350
• Device Lot Number: REDP2191
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1