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

Catalog Number	H965458310
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2015
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) 2015 (b)(4) complaint report was reviewed for the bioflo picc product family and the failure mode "hub broken/cracked {pasv and hybrid}." no adverse trend was identified.As received, the end user only returned the hubs with extension tubing for evaluation.The female luer lock component of one valve was confirmed to be cracked just adjacent to the molded parting line.Tooling marks were noted on each side of the hub that are consistent with marks made by hemostats.Functional testing (i.E.Leak testing) of the epoxy bond between the components was unable to be conducted due to the cracked condition of the sample.The likely root cause of the cracked female hub is due to the end user damaging the device with hemostats while attempting to remove the (bonded) luer from the hub body.(b)(4).
Event or Problem Description
As reported by (b)(4) distributor in the (b)(6), an indwelling picc was removed and replaced due to leakage (possibly at the junction between the grey hub and purple valve).One of the anesthetists, who is new, attempted to use forceps to disconnect the grey hub from the valve, not knowing that it was bonded.

• 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: 5636847
• Report Number: 1317056-2016-00021
• Device Sequence Number: 181531
• Product Code: LJS
• UDI-Device Identifier: H965458310
• UDI-Public: H965458310
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/27/2016

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: 11/30/2016
• Device Catalogue Number: H965458310
• Device Lot Number: 4829439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2016
• 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