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

Catalog Number	H965458110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2016
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 february 2016 (b)(4) complaint report was reviewed for the bioflo pasv picc product family and the failure mode "hub broken/cracked." no adverse trend was indicated.Without receiving product for evaluation, we are able to neither confirm the reported event nor determine a root cause.The most likely root cause for the cracked female valve housing is due to 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." (b)(4).Device discarded - not returned.
Event or Problem Description
As reported by (b)(4)' distributor in the (b)(4), an indwelling picc was removed due to a cracked hub.The patient condition was reported as "stable." the device was discarded.

• Brand Name: ANGIODYNAMICS / BIOFLO PASV
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5587092
• Report Number: 1317056-2016-00057
• Device Sequence Number: 13694473
• 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 Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2016

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: 07/31/2017
• Device Catalogue Number: H965458110
• Device Lot Number: 4915973
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2016
• Initial Report FDA Received Date: 04/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1