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

Catalog Number	H965750141
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2017
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 (b)(6) 2017 angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "hub detached." no adverse trend was identified.Returned for evaluation were two {2} unopened / unused bioflo picc kits from the same lot as the reported device.The product sample from the reported event was not returned.No visual defects were noted to the unused samples.A firm tug test was performed by hand on the epoxy bond site of the hub and the oversleeve section of the returned bioflo picc samples.The connection between the two component remained attached.The reported event was unable to be confirmed and a root cause unable to be identified, as the used device was not returned.All piccs are subjected to a 100% in process visual inspection for molding defects and a guidewire insertion test to verify lumen patency.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, picc placed in the icu.As soon as the nurse left the icu one of the hubs fell off the dual lumen picc.The picc nurse did an over-the-wire exchange with a new picc.She checked the hubs on the 2nd picc and they were secure.The patient condition was reported as "stable.".

• Brand Name: BIOFLO / ANGIODYNAMICS
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6744558
• Report Number: 1317056-2017-00059
• Device Sequence Number: 13666980
• Product Code: LJS
• UDI-Device Identifier: H965750141
• UDI-Public: H965750141
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131038
• 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): 07/26/2017

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: 04/30/2019
• Device Catalogue Number: H965750141
• Device Lot Number: 5188513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 07/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR