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

Model Number	45832
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It has been indicated that the device from the reported event will be returned for evaluation, however, it has not yet been received.Upon completion of the investigation a supplemental medwatch will be submitted.(b)(4).** the initial mdr for this complaint record was originally submitted on (b)(6) 2016 via usps.Due to e-submitting requirements, it was not accepted.Per request, this initial mdr report is being submitted via the esubmitter program.The original mdr has been attached for reference.
Event or Problem Description
As reported by angiodynamics' distributor in (b)(6), picc placed on (b)(6)2015 was removed and replaced due to leakage at the luer hub.The hub was determined to be cracked.A luer slip syringe had been used for maintenance.Ice medical tpn needleless connector was used at the outset.The lumen was used for pn.No patient complications were reported for this event.

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801, ny
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801, ny
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, ny 12801, ny ; 7424488
• MDR Report Key: 5571048
• Report Number: 1317056-2016-00034
• Device Sequence Number: 19441264
• 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: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2020

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: 05/31/2017
• Device Model Number: 45832
• Device Catalogue Number: H965458320
• Device Lot Number: 4879470
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2016
• Supplement Date Received by Manufacturer: 02/17/2016
• Initial Report FDA Received Date: 04/12/2016
• Supplement Report FDA Received Date: 04/12/2016
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown