MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (15CM); CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	5833150
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged dialysis catheter was confirmed; however, the root cause was not identified.The product returned for evaluation was two photographs which depicted a portion of dialysis catheter.The clamp markings and molded joint markings were partially worn.Damage was observed in the depicted red-lured lumen just proximal of the clamp.The catheter appeared deformed in the vicinity of the damage.While damage appeared to be visible in the submitted photographs, inspection of those photographs was insufficient to identify the root cause(s) of that damage.Potential contributing factors include sharp instrument contact and use of non-approved cleaning agents to maintain the catheter insertion site.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the catheter was inserted approximately three weeks ago.Today as the nurse was preparing to dialyze the patient she noticed that the catheter had cracked at the clamping site of the arterial lumen.The patient needs to undergo catheter removal and reinsertion procedures.No patient injury reported.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (15CM)
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7053943
• Report Number: 3006260740-2017-02109
• Device Sequence Number: 16680341
• Product Code: MSD
• UDI-Device Identifier: 00801741013317
• UDI-Public: (01)00801741013317
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

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: 5833150
• Device Catalogue Number: 5833150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR