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

Catalog Number	H965458940
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records was performed for the 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 recent angiodynamics complaint report was reviewed for the bioflo picc product family for the failure mode "hub broken/cracked." no adverse trends were indicated.The complaint of a cracked hub was confirmed through photographs provided.The likely root cause for the crack is an over-tightened connection with a mating male luer (likely a needleless connector).Inadequate flushing of the device may also be a contributing factor.The directions for use (dfu) supplied with the reported picc device contains caution that "repeated overtightening may reduce hub connector life," and not to use hemostats to "secure or remove devices with luer lock hub connections." recommended flushing techniques are also stated in the dfu.((b)(4)).
Event or Problem Description
As reported by angiodynamics' distributor in (b)(4), indwelling bioflo picc was removed due to a cracked hub.While the exact implant and explant dates are not known, explantation was on or earlier than (b)(6) 2018.No patient injury or complications were reported.

• 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: 7888883
• Report Number: 1317056-2018-00174
• Device Sequence Number: 2488263
• Product Code: LJS
• UDI-Device Identifier: H965458940
• UDI-Public: H965458940
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2018

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: 10/31/2018
• Device Catalogue Number: H965458940
• Device Lot Number: 5096452
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1