MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIO FLO; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	H965440140
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no lot number was provided, a ship history report (shr) was generated for item number (h965440140) in order to ascertain the last three lots shipped to the reporting hospital in the six months prior to the procedure date.The device history records for the lots obtained through the shr were reviewed 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 march 2016 angiodynamics complaint report was reviewed for the bioflo ports product family and the failure mode "occluded - removed." no adverse trend was indicated.The reported complaint description cannot be confirmed, nor can a root cause be identified, as no sample was returned for evaluation.Angiodynamics process controls in place for this device include 100% aspiration of port valve assemblies at qa incoming.Valve assemblies are then sent back to supplier to be assembled into ports.Pasv valve crack testing: valves are 100% tested for aspiration pressure prior to being assembled into port bodies, and port 100% hydrostatic air test (hat): valves are 100% tested for infusion pressure after being assembled to port bodies.
Event or Problem Description
Patient had a bioflo port placed less than a year ago.He responded well to his chemo, had completed his therapy, and was currently just maintaining the port.The infusion nurses were not able to flush it (occluded with an obvious clot), so they decided to send him back to dr.(b)(6) for the removal.

• Brand Name: ANGIODYNAMICS / BIO FLO
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5742130
• Report Number: 1317056-2016-00086
• Device Sequence Number: 24422
• Product Code: LJT
• UDI-Device Identifier: H965440140
• UDI-Public: H965440140
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2016

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: H965440140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2016
• Initial Report FDA Received Date: 06/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1