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

Catalog Number	H965750171
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2017
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 recent angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "hub broken." no adverse trends were identified.As received, the hub on the returned catheter was broken at the barbed section of the valve.A piece of the barbed end of the hub remained inside the oversleeve.The broken hub appears to have been caused by exertion of excessive force on the valve component.No manufacturing non-conformances or out of specification conditions were observed during sample evaluation.While a definitive root cause for the damage to the hub could be determined from the sample review, the damage appears to have been caused by exertion of excessive force on the valve component and not related to the manufacturing process.Angiodynamics' manufacturing process controls for the bioflo picc include visual inspection of all molded components to insure that they are free from molding non-conformities, as well as dimensional inspections.(b)(4).
Event or Problem Description
As reported, the hub of an implanted picc was noticed to be broken one day after insertion.The picc was removed and returned to angiodynamics.No patient complications were reported.

• 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: 6955182
• Report Number: 1317056-2017-00087
• Device Sequence Number: 19117964
• Product Code: LJS
• UDI-Device Identifier: H965750171
• UDI-Public: H965750171
• 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): 10/17/2017

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: Other Health Care Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: H965750171
• Device Lot Number: 5215360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1