MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EQUISTREAM XK LONG-TERM HEMODIALYSIS CATHETER; DIALYSIS CATHETER, IMPLANTED, SUBCUTANEUOS, IMPLANTED

Model Number	5913350
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A photograph of the device was received for evaluation.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.
Event or Problem Description
It was reported that upon unpacking, the tunneler tip allegedly was identified as broken.There was no reported patient contact.
Additional Manufacturer Narrative
Manufacturing review: the lot met all release criteria.Dhr was reviewed and no deviations/issues were identified associated with this problem in regards to product materials or during packaging, manufacturing or qc inspection processes.Investigation summary: although the sample was not returned for evaluation, two electronic photos were provided for review.After reviewing the photos, the investigation is confirmed for broken tunneler, as the photo review shows the entire equstream kit with the broken tunneler tip sitting on top of the rest of the untouched kit.There is also a scar that suggests this complaint is part of a larger issue that is being investigated.The definitive root cause for the reported damaged tunneler issue could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the 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.
Event or Problem Description
It was reported that upon unpacking, the tunneler tip allegedly was identified as broken.There was no reported patient contact.

• Brand Name: EQUISTREAM XK LONG-TERM HEMODIALYSIS CATHETER
• Common Device Name: DIALYSIS CATHETER, IMPLANTED, SUBCUTANEUOS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8373939
• Report Number: 3006260740-2019-00383
• Device Sequence Number: 13983413
• Product Code: MSD
• UDI-Device Identifier: 00801741013874
• UDI-Public: (01)00801741013874
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K090101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

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: 5913350
• Device Catalogue Number: 5913350
• Device Lot Number: RECZ0711
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1