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

Catalog Number	H96560M0104331
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2016
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 (b)(6) 2016 angiodynamics complaint report was reviewed for the bioflo pasv picc product family for the failure mode "hub broken/cracked." no adverse trends were indicated.As received, the female luer lock component of the white valve on the picc was confirmed to be cracked just adjacent to the molded parting line.There was an injection cap/needleless connector (not supplied by angiodynamics) attached to each female luer lock valve hub, and a green curos cap attached to the injection cap of the white/purple valve.Curos caps have a sponge on the inside soaked with isopropyl alcohol.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 end user hospital.Indwelling picc was removed and replaced due to a cracked hub.No patient complications were reported.The used device has been returned 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: 5787375
• Report Number: 1317056-2016-00104
• Device Sequence Number: 342088
• Product Code: LJS
• UDI-Device Identifier: H96560M0104331
• UDI-Public: H96560M0104331
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/17/2016

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: H96560M0104331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2016
• Initial Report FDA Received Date: 07/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1