MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number	H965750335
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/13/2017
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 2017 angiodynamics complaint report was reviewed for the bioflo picc product family and for the failure mode "catheter occluded - removed." no adverse trend was identified.The end user hospital's reported complaint description cannot be confirmed as no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Potential contributing factors for this complaint may be catheter positioning techniques used during the placement procedure or patient anatomy.The directions for use provided with the picc device contains the following precautionary statements: "- if catheter and accessories show any sign of damage (crimped, crushed, cut, etc.), do not use.- do not fully insert catheter up to suture wing.- avoid sharp or acute angles during insertion which may compromise catheter functionality.- following institutional policy, secure catheter externally to prevent catheter movement, migration, damage, kinking or occlusion." angiodynamics' manufacturing process controls for the bioflo picc include a 100% in-process visual inspection for molding defects and a guidewire insertion test to verify lumen patency is required.In addition, all catheters are 100% sprint tested after the guidewire verification to ensure the catheter does not leak.(b)(4).
Event or Problem Description
As reported, 5f bioflo picc "used on small vessels upon assessment - upper arms." initial insertion on (b)(6) 2017 by picc rn.No blood return or flushing function was noted 12 hours after insertion.Picc was removed and exchanged at the same site by ir md under fluoro on (b)(6) 2017.The initial picc was examined at the hospital and did not have any debris inside.It flushed well outside the patient.It was also free of any thrombin/clot adhesion on the external parts of the picc.Cathflo had been utilized.The removed picc was discarded at the hospital.

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6990807
• Report Number: 1317056-2017-00088
• Device Sequence Number: 10884622
• Product Code: LJS
• UDI-Device Identifier: H965750335
• UDI-Public: H965750335
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K163452
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/01/2017

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: Nurse
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: H965750335
• Device Lot Number: 5234874
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR