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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO; PERIPHERALLY INSERTED CENTRAL CATHETER
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ANGIODYNAMICS ANGIODYNAMICS / BIOFLO; PERIPHERALLY INSERTED CENTRAL CATHETER Back to Search Results
Catalog Number H965458320
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/02/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device from the reported event has not yet been returned to angiodynamics.Upon receipt of the sample / completion of the investigation, a supplemental medwatch will be submitted.(b)(4) : device not yet returned to manufacturer.
 
Event or Problem Description
As reported by angiodynamics' distributor in the (b)(6), a picc device was removed due to a cracked hub.No patient injury or complications were indicated.
 
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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 Key5864480
Report Number1317056-2016-00115
Device Sequence Number695976
Product Code LJS
UDI-Device IdentifierH965458320
UDI-PublicH965458320
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K121089
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2016
Reporter Type Manufacturer
Report Source distributor,foreign,user faci
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/19/2016
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 Catalogue NumberH965458320
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/19/2016
Initial Report FDA Received Date08/10/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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