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

Catalog Number	H96560M0224751
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used device has been returned to angiodynamics, however, the investigation is still ongoing.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported, patient had bioflo picc line removed and replaced due to leakage at the extension leg.Picc was placed on (b)(6) 2017.Patient released to home on (b)(6) 2017 with picc for antibiotics.Picc removed and replaced on (b)(6) 2017.No patient complications reported.The used device has been returned to angiodynamics for evaluation.
Additional Manufacturer Narrative
In lieu of a reported lot number, a ship history report (shr) was generated for item number (h96560m0224751) in order to ascertain the last three lots shipped to the reporting hospital in the six months prior to the procedure date.A review of the device history records was performed for the identified 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 june 2017 angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "catheter leaked - removed." no adverse trends were identified.Visual examination of the returned catheter confirmed a hole/fracture in the extension tubing at the junction with the oversleeve.No manufacturing non-conformance or out-of -specification conditions were observed during the sample evaluation.The id and od of the catheter were measured and found to meet specification.The location of the fracture on the extension tube, approximately 2mm from the junction with the oversleeve, is not indicative of damage from the insert molding process, but likely to be the result of handling damage, specifically that the tubing was possibly cut by a scalpel during the picc placement procedure or by scissors during a dressing change.As noted during the review of the directions for use (dfu) item number 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." all bioflo picc catheters are subjected to 100% in-process visual inspection for damage and/or defects.A guidewire insertion test is performed to ensure lumen patency, and leak testing is performed on all catheters after guidewire verification.((b)(4)).

• 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: 6394530
• Report Number: 1317056-2017-00026
• Device Sequence Number: 737436
• Product Code: LJS
• UDI-Device Identifier: H965458110
• UDI-Public: H965458110
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2017

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 Catalogue Number: H96560M0224751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2017
• Supplement Date Received by Manufacturer: 02/15/2017
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR