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

Catalog Number	H965458110
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records was performed for the 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 recent angiodynamics complaint report was reviewed for the bioflo picc product family for the failure mode "hub broken/cracked".No adverse trends were indicated.The complaint of a cracked hub was confirmed.Returned for evaluation was a catheter with a needleless connector (not supplied by angiodynamics) attached to it.The female luer lock component of the purple valve was confirmed to be cracked just adjacent to the molded parting line.No other visual defects were noted to the valve or catheter.A possible root cause for the crack is an over-tightened connection with a mating male luer (likely the needleless connector).Inadequate flushing of the device may also be a contributing factor.The directions for use (dfu) supplied with the reported picc device contains caution that "repeated overtightening may reduce hub connector life," and not to use hemostats to "secure or remove devices with luer lock hub connections".Recommended flushing techniques are also stated in the dfu.((b)(4)).
Event or Problem Description
As reported by angiodynamics distributor in (b)(6), picc inserted on (b)(6) 2018 with no complications.The extension tube was changed weekly as per protocol.The bioflo picc was reported leaking by the oncology dept.On (b)(6) 2018.When the patient was sent to radiology and the catheter was flushed it leaked and was drawing back air rather than fluid.On investigation, the hub of the picc was cracked.The picc was removed and a new picc was inserted.The used device has been returned to angiodynamics.

• 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: 7655365
• Report Number: 1317056-2018-00127
• Device Sequence Number: 1146326
• Product Code: LJS
• UDI-Device Identifier: H965458110
• UDI-Public: H965458110
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2018

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: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: H965458110
• Device Lot Number: 5297565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR