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

Model Number	5833350
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Photos were provided for review.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.
Event or Problem Description
It was reported that during a dialysis catheter placement the introducer needle was inserted under ultrasound guidance and allegedly fluid was leaking from the hub during aspiration.Reportedly, it was identified that the hub allegedly ruptured.A new kit was opened to complete the procedure.There was no reported patient injury.
Additional 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: one hemostar dual-lumen radiopaque catheter, two end caps, one tunneler, one dilator, one dualator, one guidewire in a guidewire hoop, one airguard valved introducer peel-apart sheath and dilator were returned for evaluation.A gross visual evaluation was performed.Two photos were also returned and were reviewed.The investigation is confirmed for cracked introducer needle hub, as two cracks at the proximal end of the introducer needle hub were identified during the photo review.The introducer needle was not returned with the sample and could not be evaluated in the fa biohazard lab.The dilator in the returned kit was observed to be bent.The returned sample appeared to be clean.The definitive root cause could not be determined based upon available information.It is unknown if procedural issues contributed to the reported event.Labeling review: the cause of the event in question is unknown, and so the applicability of any particular portion of the instructions for use (ifu) or other labeling is unknown.However, 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 ifu instructs on the use of the needle and that accessories/components used in conjunction with this catheter should incorporate luer-lock adapters.Therefore, the product labeling will be considered adequate.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 or Problem Description
It was reported that during a dialysis catheter placement the introducer needle was inserted under ultrasound guidance and allegedly fluid was leaking from the hub during aspiration.Reportedly, it was identified that the hub allegedly ruptured.A new kit was opened to complete the procedure.There was no reported patient injury.

• Brand Name: HGSTAR, 14.5 FR, ST, 35CM STAND
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9142052
• Report Number: 3006260740-2019-02892
• Device Sequence Number: 1824719
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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
• Operator of Device: Health Professional
• Device Model Number: 5833350
• Device Catalogue Number: 5833350
• Device Lot Number: REDP2191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 43