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

Catalog Number	H965458820
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2018
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 "blood back up in valve/extension tube {removed}." no adverse trend was identified.As received, the catheter had been trimmed to the 43cm mark.The catheter was contaminated clear fluid in the extension tubing.No blood was noted to the purple valve extension tubing.The valve was visualized microscopically and the valve disc was confirmed to be slit and centered.There were no molding/manufacturing related non-conformances noted to the returned catheter, nor were kinks, compressions or other damage noted.During the cleaning process a 10ml syringe was used to infuse the cleaning solution through the valve and through the catheter.Infusion was performed with no difficulties.A guidewire (0.018") was inserted through the lumens of the returned sample without difficulty, confirming patency.The infusion and aspiration pressures were measured and were found to meet specification.The catheter tubing tip id and od were also measured and meet specification.The reported complaint issue of blood backing up into the valve was unable to be confirmed by the testing of the returned sample, nor could a potential root cause be determined.The returned catheter met all dimensional and functional requirements when tested.Angiodynamics' manufacturing process controls for the bioflo pasv picc include visual inspection for molding damage, 100% guidewire insertion testing for lumen patency, and 100% sprint leak testing after the guidewire verification to ensure the catheter does not leak.Additionally, 100% infusion testing and aspiring testing is performed on all valves to verify that they open and close correctly under a defined amount of pressure.Valves must pass both tests to be released.(b)(4).
Event or Problem Description
As reported by end user hospital in the (b)(6), "several days after insertion (of a bioflo valved picc) after withdrawl of blood, there was a continuous backflow of blood." the line was removed and replaced by a similar device.The used picc 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: 7241421
• Report Number: 1317056-2018-00008
• Device Sequence Number: 16364442
• Product Code: LJS
• UDI-Device Identifier: H965458820
• UDI-Public: H965458820
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2018

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: Physician
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: H965458820
• Device Lot Number: 5213191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1