MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO; PORT / CATHETER IMPLANTED

Catalog Number	H965440250
Medical Device Problem Code	Aspiration Issue (2883)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	05/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It has been indicated that the used port will be returned to angiodynamics for evaluation, however it has not yet arrived.Upon receipt of the sample and completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
Details of the problem as provided by the patient are that a bioflo port was implanted on (b)(6) 2017 after an operation for rectal cancer.Multiple nurses / needle sticks were needed to access the port on (b)(6) for an iv.The physician was finally able to access.On march 29, 4 nurses again were needed before access was obtained to draw blood from the port.After the multiple attempts on (b)(6), "the port area was sore and very swollen." the port was removed on (b)(6) 2017 and will be returned to angiodynamics for evaluation.
Additional Manufacturer Narrative
As no lot number was provided, a ship history report (shr) was generated for item number h965440250 in order to determine the last three lots shipped to the reporting customer 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 august 2017 angiodynamics complaint report was reviewed for the bioflo port product family and the failure mode "miscellaneous functional {removed}." no adverse trend was identified.The used port was returned with the catheter attached to the port at the 29cm mark.The connector was not fully seated to the port.There were tool marks noted on each side of the connector.The tool marks noted are consistent with damage caused by over tightening the connector on to the port using hemostats.Infusion and aspiration of water was performed using a non-coring needle and a 10 cc syringe without difficulty.No occlusion in lumen was observed.However, bio-material {blood} was removed during the cleaning process.The port was pressurized with air at 50 psi and submerged under water for 30 seconds.No leaks were observed.A snap lock connector was connected to the 8f port.The snap lock connector functioned properly.The snap lock connector id and pocket depth dimensions were measured and found to meet specification.The catheter tubing id and od dimensions were also found to meet specification.The reported complaint description of being unable to access the port could not be confirmed.The port functioned normally during infusion and aspiration and no leaks were detected.No manufacturing non-conformances or out of specification conditions were observed during sample evaluation.The directions for use (dfu) provided with the port provide guidance on assembly of the catheter to the port.As received, the sample did not have the connector fully seated to the port, however this should not have had an impact on the reported inability to access the port.Operational context is the more likely cause.(b)(4).

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: PORT / CATHETER IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6725652
• Report Number: 1317056-2017-00057
• Device Sequence Number: 10970587
• Product Code: LJT
• UDI-Device Identifier: H965440250
• UDI-Public: H965440250
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K131694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other Health Care Professional
• Device Catalogue Number: H965440250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other