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

Catalog Number	H965458890
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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) 2016 angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "extension tubing hole / damage." no adverse trend was applicable.A visual inspection of the device sample confirmed the end user's description of a leak in the extension tubing: there was a slice in the extension tubing proximal to the suture wing on the purple/shite valve side.The tip of the catheter tubing was occluded with bio material {blood}.The extension tubing was sectioned approximately one inch above the hole.Visual inspection of the cross section did not show any abnormalities.A dimension check of the tubing id and od showed it to be within specification.While the exact root cause of the damage to the tubing is unable to be determined, it is possible it was caused by a scalpel or sharp instrument during use.The directions for use packaged with the device include cautions against over-pressurization of the catheter as well as the statement, "do not use clamps or instruments with teeth or sharp edges on the catheter, as catheter damage may occur." angiodynamics manufacturing process controls include 100% visual inspection of all catheters for damage or defects, 100% leak testing, and 100% guidewire insertion test to verify lument patency.(b)(4).
Event or Problem Description
As reported per bedside rn, leaking at the site of the picc.Vad/picc team evaluated picc line, ultrasound was used and basilic vein which houses the picc is patent and compressible.Purple port flushes easily and w/ good blood return, white port when flushing noticed squirting by the clear extension tubing near the statlock and y junction.The picc was removed and replaced.Patient condition was reported as "unaffected / stable.".

• Brand Name: ANGIODYNAMICS / BIOFLO PASV
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5636901
• Report Number: 1317056-2016-00062
• Device Sequence Number: 522764
• Product Code: LJS
• UDI-Device Identifier: H965458890
• UDI-Public: H965458890
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/07/2016

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 Expiration Date: 02/28/2018
• Device Catalogue Number: H965458890
• Device Lot Number: 4991984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2016
• Initial Report FDA Received Date: 05/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1