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

Catalog Number	H96560M7019941
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used device from the reported event has been returned to angiodynamics.As the sheath/dilator is a purchased device, angiodynamics will be forwarding the sample to greatbatch medical for evaluation and completion of a supplier corrective action request (scar).Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).
Event or Problem Description
As reported by hospital in (b)(6), "when breaking away the peel-away portion of the introducer, both handle portions of the plastic introducer broke off of the sheath before (b)(6) had completed the peel away from the dilator.She was able to successfully retrieve all portions of the peel away sheath before it went under the skin.".
Additional Manufacturer Narrative
A review of the lot history records was performed for packaging lot 5470109 for item number h96560m7019941 for any deviations related to the reported defect of the complaint.In addition, the lot history records for introducer dilator/sheath 5f 5cm peel.018"wire p/n: 10600706 l/n: 655517 were reviewed.The review confirmed that the packaging lot and all component lots met all material, assembly, and performance specification.The september 2019 angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "sheath detached/separated/fractured." no adverse trend was identified.In addition, this is the only reported complaint for this sheath failure mode for the bioflo picc product family in the past 15 months.The used sheath was returned in 4 pieces (i.E., the tubing was detached from each of the 2 handles).As this is a purchased component for angiodynamics, the sample was forwarded to the manufacturer, greatbatch mfg., for evaluation, along with a scar (supplier corrective action response).Greatbatch's completed response indicated that the root cause of the event was that the sheath "mold does not fasten the tube adequately during the over-molding process, causing it to move the core-pin and not create an adequate mechanical bond between the sheath and the handle." greatbatch has implemented a short-term corrective action: they performed an awareness training and have implemented sorting of quarantined devices - 100% sorting of material on-hand and subsequent increased sampling levels.The long-term corrective action was noted as having the tube retention fixture validated and implemented.((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: 8807112
• Report Number: 1317056-2019-00095
• Device Sequence Number: 342687
• Product Code: LJS
• UDI-Device Identifier: H96560M7019941
• UDI-Public: H96560M7019941
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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: 03/31/2021
• Device Catalogue Number: H96560M7019941
• Device Lot Number: 5470109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1