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

Catalog Number	H965750161
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated packaging and picc assembly 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 recent angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "oversleeve - extension tubing/hole fracture." no adverse trend was identified.Visual inspection of the returned catheter confirmed that there was a hole/slice in the extension tubing.No manufacturing non-conformances or out of specification conditions were observed during the sample evaluation.Measurements were taken using pin gauges and calipers of the extension tubing id and od.Both were found to meet specification.While a definitive root cause for the damage to the device could not be determined, the slice in the extension tubing was potentially caused by a scalpel or scissors, and occurred during use of the device.Angiodynamics' process controls for the bioflo picc include 100% visual in section for damaged tubing, 100% guidewire insertion testing to verify lumen patency, followed by 100% leak testing.The directions for use supplied with the reported picc contains the cautions, " do not use sharp instruments near the extension tubes or catheter shaft," and "do not use scissors to remove the dressing, as this may possibly cut or damage the catheter." angiodynamics' manufacturing process controls for the bioflo picc include a 100% in-process visual inspection that includes, but is not limited to visualizing for bent hub at tubing point, short shots, sink marks, flash, and splay, an end-of-lot visual inspection based on an aql for molding defects that includes but is not limited to visualizing for over melts, flash, blow-bys, short shots, pinch marks and verifying product was molded per the drawing.Additionally, various dimensional verifications and a tensile test of the extension tube to overmolded sleeve based on an aql are performed.A guidewire insertion test to verify lumen patency is required.In addition, all catheters are 100% sprint tested after the guidewire verification to ensure the catheter does not leak.An end of lot inspection based on an aql is performed that includes a visual inspection inclusive of, but not limited to, handling damage such as scratches cuts and kinks.A sprint air/burst test for leakage and a fluid burst test based on an aql are also performed.(b)(4).
Event or Problem Description
Female patient (b)(6) years old.The picc line was placed on (b)(6) 2017 and removed on (b)(6) 2017.The bedside nurse noted the picc line was leaking during a routine flush.The line was cracked between the extension leg and the hub just below the white oversleeve mold.The picc was being used for chemotherapy, and was not replaced.The remainder of the chemotherapy was able to be infused via a peripheral iv.Site care protocol: hospital uses chg cleaner every 7 days for dressing changes and scrubs the hub with alcohol between medications and any time the line is accessed.The used device has been returned to angiodynamics for evaluation.

• 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: 6951809
• Report Number: 1317056-2017-00082
• Device Sequence Number: 16421764
• Product Code: LJS
• UDI-Device Identifier: H965750161
• UDI-Public: H965750161
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K163452
• 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): 10/16/2017

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: Other Health Care Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: H965750161
• Device Lot Number: 5100444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR