MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HGSTAR, 14.5 FR, ST, 27CM, STAND; DIALYSIS CATHETER

Model Number	5833270
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2019
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.(expiration date: 09/2020).
Event or Problem Description
It was reported that during dialysis catheter placement, the plastic sleeve of the tunneler component allegedly broke.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: as the lot number for the device was provided, a manufacturing review was not required to be performed.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 ifu instructs on the use of the tunneler, and therefore the product labeling will be considered adequate.Investigation summary: one plastic tunneler sleeve was returned for evaluation.A gross visual evaluation was performed on the returned sample.Two electronic photos were also provided.A photo review was performed.The investigation is confirmed for damaged tunneler sleeve, as damage along almost the entirety of the sleeve length was identified by both the photo review and the sample evaluation.During the sample evaluation, the split was observed to be jagged and extend approximately 3.2 cm from the proximal conical end of the tunneler sleeve.The sample was observed to be bloody.There appeared to be a crease extending from the distal end of the split and ending near the distal end of the sleeve.The definitive root cause could not be determined based upon available information.
Event or Problem Description
It was reported that during dialysis catheter placement, the plastic sleeve of the tunneler component allegedly broke.There was no reported patient injury.

• Brand Name: HGSTAR, 14.5 FR, ST, 27CM, STAND
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9282694
• Report Number: 3006260740-2019-03452
• Device Sequence Number: 16683763
• Product Code: MSD
• UDI-Device Identifier: 00801741013324
• UDI-Public: (01)00801741013324
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

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: 5833270
• Device Catalogue Number: 5833270
• Device Lot Number: REDN0131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 90