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

Catalog Number	H965458830
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2019
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 recent angiodynamics complaint report was reviewed for the bioflo picc product family for the failure mode "catheter/extension leg leaked".No adverse trend was identified.As no device sample was returned to angiodynamics for evaluation, the reported issue could not be confirmed, nor could a potential root cause be established.The directions for use packaged with the bioflo piccs contain cautions and warnings regarding the use of sharp objects in opening packagings or near the extension tubes or catheter shaft.((b)(4)).
Event or Problem Description
As reported by hospital in (b)(6), following implantation of picc in patient's upper arm, leakage was noted at the area of the hub over sleeve.The catheter was removed and replaced.There were no patient complications and the catheter was discarded at the hospital.

• 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: 8326027
• Report Number: 1317056-2019-00034
• Device Sequence Number: 19261708
• Product Code: LJS
• UDI-Device Identifier: H965458830
• UDI-Public: H965458830
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2019

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: Lay User/Patient
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: H965458830
• Device Lot Number: 5323137D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1