MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN HEMODIALYSIS/APHERESIS CATHETER 13.5F DUAL-LUMEN CATHETER; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	0600660
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not yet returned for evaluation.
Event or Problem Description
Facility contact reported that on (b)(6) 2016, stem cell infusion was started and it was noted that the hickman catheter leaked at the insertion site.A.60 ml of the 100ml syringe had already been infused when leakage noted.The reported leaking was noted on (b)(6) 2016 while chemotherapy was infusing.Patient had been sent to interventional radiology where line was said to be ok and no leaking noted.The hickman was removed from patient on (b)(6) 2016.The patient did not receive full compliment of stem cells.On 07/20/2016 - additional information received from the complainant stating that the leaking was around the insertion site as far as they could tell.When the leak was first noticed, the patient's dressing was wet and had leaked onto her gown.The chemo was stopped.The patient was sent to ir.No leak was found but a sheath was present; the catheter was reported to be good for use.The next day, the complainant checked the catheter and began infusing stem cells and noticed leaking around the catheter site.The catheter was removed and placed in a sealed bag.No tests were done to it to determine if the leak was on the external portion of the catheter.
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 leaking dialysis catheter was unconfirmed because the reported problem could not be reproduced.The product returned for evaluation was one 13.5fr hickman dialysis catheter.Usage residues were observed throughout the sample.Tissue residue was observed within the ingrowth cuff.An attempt to infuse water through the sample using a 12ml syringe revealed both lumens to be patent to infusion and aspiration with no observed leaks.No leaks were observed during sustained (> 30 seconds) hydraulic pressurization of the sample.Tactile inspection of the sample was unremarkable.Microscopic inspection of the sample did not reveal any damage or manufacturing defects.No deficiencies were discovered through evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.

• Brand Name: HICKMAN HEMODIALYSIS/APHERESIS CATHETER 13.5F DUAL-LUMEN CATHETER
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5867213
• Report Number: 3006260740-2016-00405
• Device Sequence Number: 13553978
• Product Code: LJS
• UDI-Device Identifier: 00801741037504
• UDI-Public: (01)00801741037504
• Combination Product (Y/N): N
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2016

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 Catalogue Number: 0600660
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2016
• Supplement Report FDA Received Date: 09/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1