MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO; DIALYSIS CATHETER

Catalog Number	H965103038041
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The september 2016 angiodynamics complaint report was reviewed for the bioflo dialysis product family and the failure mode "catheter fell out of patient." no adverse trend was indicated.In addition, this is the only reported complaint for this failure mode in the past 15 months for the bioflo dialysis product family.The root cause of the reported complaint description cannot be determined as no sample was returned for evaluation.The directions for use packaged with the device include instructions for catheter placement and securement.(b)(4).Device discarded.
Event or Problem Description
As reported by hospital in canada, patient had had a bioflo dialysis catheter placed on (b)(6) 2016.Catheter fell out while he was taking a shower at his home on (b)(6) 2016.This was not noticed until he came in to the hospital later that day for "extra treatment." per the complaint reporter, the patient's condition was described as "stable." the catheter was replaced on (b)(6) 2016.The used catheter was discarded / will not be returned for evaluation.

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6092766
• Report Number: 1317056-2016-00162
• Device Sequence Number: 16305179
• Product Code: MSD
• UDI-Device Identifier: H965103038041
• UDI-Public: H965103038041
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2016

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 Expiration Date: 07/31/2018
• Device Catalogue Number: H965103038041
• Device Lot Number: 5007370
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2016
• Initial Report FDA Received Date: 11/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR