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

Catalog Number	M001454580
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	12/23/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no lot number was provided, a ship history report (shr) was generated for the reported item number in order to determine the last 3 lots shipped to the reporting hospital in the six months prior to the event date.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 june 2016 angiodynamics complaint report was reviewed for the vaxcel pasv picc product family for the failure mode "hub broken/cracked." no adverse trends were indicated.Although no sample was returned for evaluation, a potential root cause for the reported cracked hub may have been an over-tightened connection with a mating male luer (likely a 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.".
Event or Problem Description
As reported by hospital in (b)(4), the hub of a valved picc cracked and leaked during flushing.The device was removed.No patient complications were reported.

• Brand Name: ANGIODYNAMICS / VAXCEL PASV
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5904203
• Report Number: 1317056-2016-00126
• Device Sequence Number: 10966425
• Product Code: LJS
• UDI-Device Identifier: M001454580
• UDI-Public: M001454580
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/27/2016

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 Catalogue Number: M001454580
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2016
• Initial Report FDA Received Date: 08/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1