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

Catalog Number	H96560M1834821
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device from the reported incident is not expected to be returned for evaluation, the investigation into this event is on-going.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported, patient had picc line placed (b)(6), 2017.Line became non-functioning.Picc line service nurse removed picc line from patient on (b)(6) 2017 and found it to contain a segment which appeared to be "deflated and stretched." another picc line was placed.No sample is expected to be returned.
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 august 2017 angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "device/catheter malfunctioned - removed." no adverse trend was identified.The end user's reported complaint description of "picc appeared deflated and stretched" is not confirmed, nor can a root cause be determined, as no sample was returned for evaluation.Angiodynamics' incoming inspection of the catheter tubing includes a visual inspection based on an aql, which includes but is not limited to, visualizing for dents in the catheter tubing.Dents that can be felt, but not seen are acceptable; dents that can be felt and seen are rejectable.In addition, a guidewire insertion test is performed.The guidewire must pass through the entire length of the extrusion with no resistance.Manufacturing process controls include visual inspection for damage or defects.All catheters are subjected to a guidewire insertion test to verify lumen patency.The guidewire must pass through the catheter with little to no resistance to be considered acceptable.In addition, all catheters are 100% sprint tested after the guidewire verification to ensure the catheter does not leak.The directions for use provided with the picc device provide guidance on catheter placement, and flushing.((b)(4)).

• Brand Name: ANGIODYNAMICS / BIO FLO
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6848195
• Report Number: 1317056-2017-00071
• Device Sequence Number: 750951
• Product Code: LJS
• UDI-Device Identifier: H96560M1834821
• UDI-Public: H96560M1834821
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K5121089
• 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,Followup
• Report Date (Section B): 09/20/2017

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: 03/31/2019
• Device Catalogue Number: H96560M1834821
• Device Lot Number: 5186436
• 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: 08/11/2017
• Supplement Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR