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

Catalog Number	H965458950
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The end user hospital has been contacted in an effort to obtain more information about this event.The device sample is expected to be returned to angiodynamics for evaluation, but has not yet arrived.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported, an indwelling picc was removed and replaced due to a cracked hub.No patient injury or complication was reported.The used picc will be returned to angiodynamics for evaluation.
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 device from the reported event was returned to angiodynamics and the complaint of a cracked hub was confirmed.The female luer lock component of the white valve was seen to be cracked just adjacent to the molded parting line.There were no other visual defects noted to the hub or catheter.A possible 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 contain 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).

• 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: 7352054
• Report Number: 1317056-2018-00027
• Device Sequence Number: 1093994
• Product Code: LJS
• UDI-Device Identifier: H965458950
• UDI-Public: H965458950
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K133264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

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: Nurse
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: H965458950
• Device Lot Number: 5279319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1