MAUDE Adverse Event Report: ANGIODYNAMICS BIOSTABLE PICC WITH PASV; PERIPHERALLY INSERTED CENTRAL CATHETER,

Model Number	45811
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description cannot be confirmed, no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A device history report review of the packaging and component lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.This customer filed similar complaint per (b)(4) with 2 samples returned for evaluation that were determined to meet printing specification.The bioflo picc products printed with the marabu ink systems (white ink on catheter tubing) and its ancillary(s) and packaging have been tested and are considered biocompatible for its/their intended use as en iso 10993-1 category: circulating blood path contact with > thirty (30) days exposure.A review of the device history records was performed for the reported 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 issue is considered cosmetic and does not affect the functionality of the device.Labeling review: the dfu that is supplied in bioflo kits item number {16600224-01} contains the following precaution:.Do not use the catheter with chemicals that are incompatible with any of its accessories, as catheter damage may occur.Acetone and polyethylene glycol-containing ointments should not be used with polyurethane catheters, as these may cause failure of the device.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).
Event or Problem Description
As per nurse: noticed during an exchange that the white markings on the picc, that is outside of the patient's body, had flaked off.Patient had the picc only inserted for 1 week.The picc was removed and replaced with a new of the same device.There was no patient harm or injury to the patient due to this event.It was reported the defective disposable device is not available for return to the manufacturer as it was disposed of by the user.

• Brand Name: BIOSTABLE PICC WITH PASV
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER,
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny
• MDR Report Key: 9699594
• Report Number: 1317056-2020-00020
• Device Sequence Number: 19438773
• Product Code: LJS
• UDI-Device Identifier: H965458110
• UDI-Public: H965458110
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

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: 08/31/2021
• Device Model Number: 45811
• Device Catalogue Number: H965458110
• Device Lot Number: 5519272
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1