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

Model Number	H965458320
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While it has been indicated that the device from the reported event will be returned to angiodynamics for evaluation, it has not yet arrived.Upon receipt of the sample / completion of the investigation, a supplemental medwatch will be submitted.(b)(4) not yet returned to manufacturer.
Event or Problem Description
As reported by angiodynamics' distributor in the (b)(6), " lumen of a 5fr.Bioflo picc through which parenteral nutrition was being delivered cracked on day 19 of use." the device was removed and replaced.It has been indicated that the used catheter will be returned to angiodynamics for evaluation.
Additional Manufacturer Narrative
Angiodynamics has been informed by the original event reporter that this complaint is a duplicate of another complaint they reported.The other complaint (angiodynamics complaint #(b)(4)) has been investigated and reported to the fda on medwatch 1317056-2017-00003.This complaint, represented by medwatch 1317056-2016-00176, is therefore being cancelled in angiodynamics' complaint system.((b)(4)).

• 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: 6131424
• Report Number: 1317056-2016-00176
• Device Sequence Number: 651219
• Product Code: LJS
• UDI-Device Identifier: H965458320
• UDI-Public: H965458320
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2016

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 Expiration Date: 03/31/2018
• Device Model Number: H965458320
• Device Lot Number: 5014842
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2016
• Supplement Report FDA Received Date: 01/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1