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 Consequences Or Impact To Patient (2199)
Date of Event	12/09/2015
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 angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "hub broken/cracked {pasv & hybrid}." no adverse trend was identified.As received, only the hub and extension tubing were returned for evaluation.The female luer lock component of the purple valve on the picc was confirmed to be cracked just adjacent to the molded parting line.The most likely root cause for the crack along the valve parting line is an over-tightened connection with a mating male luer (likely the needleless connector).The directions for use (dfu) supplied with the reported picc device contain caution that "repeated over-tightening may reduce hub connector life," and not to use hemostats to "secure or remove devices with luer lock hub connections." (b)(4).
Event or Problem Description
As reported by angiodynamics' distributor in (b)(6), an indwelling picc was removed and replaced due to a cracked hub.The patient condition was reported as "stable.".

• 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: 5644004
• Report Number: 1317056-2016-00023
• Device Sequence Number: 13506482
• Product Code: LJS
• UDI-Device Identifier: H965458110
• UDI-Public: H965458110
• 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): 01/28/2016

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: 06/30/2017
• Device Catalogue Number: H965458110
• Device Lot Number: 4895451
• 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: 01/28/2016
• Initial Report FDA Received Date: 05/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1