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

Catalog Number	H965458120
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2017
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 "catheter leaked - removed." no adverse trend was identified.Although no sample was returned for evaluation, a photo was provided, which clearly shows a slice in the clear extension tubing of the catheter.Since the picc leak was observed post placement procedure and after the first chemo treatment, the likely root cause is handling damage during care and maintenance of the picc.Potential handling damage includes tubing cut by scalpel during picc placement procedure or scissors during dressing change.As noted during the review of the directions for use (dfu) that is supplied in the reported kit, the following precautions/warnings are stated: "· do not use sharp instruments near the extension tubes or catheter shaft." angiodynamics' manufacturing process controls for the picc device include a visual inspection for foreign matter and damaged tubing, a guidewire insertion test to verify lumen patency, followed by 100% leak testing to ensure that the catheter does not leak.End-of-lot aql inspection includes dimensional verifications and tesile testing of the extension tube to overmolded sleeve.(b)(4).
Event or Problem Description
As reported by angiodynamics' distributor in the (b)(6), patient had valved picc placed on (b)(6) 2017.First cycle of chemotherapy given on (b)(6) 2017.During "routine weekly catheter maintenance flushing with saline," the picc was noted to be leaking from the extension tube.No complications to the patient 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: 7096101
• Report Number: 1317056-2017-00103
• Device Sequence Number: 11107290
• Product Code: LJS
• UDI-Device Identifier: H965458120
• UDI-Public: H965458120
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2017

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: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: H965458120
• Device Lot Number: 5147753
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1