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

Catalog Number	H965458110
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It has been indicated that the used device, as well as unused samples from the reported lot will be returned to angiodynamics for evaluation, however, they have not yet arrived.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported by a hospital in (b)(6), the ink markings on multiple units of bioflo picc devices are able to be rubbed off during insertion and/or cleaning.One picc has been removed and replaced (although how long it was implanted is not known).The used picc, as well as unused units from the reported picc lot, is being returned to angiodynamics for evaluation.No patient injury or complications have been reported.
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 and the failure mode "catheter markings missing/illegible." no adverse trend was indicated.Additionally, no complaints have been received on the reported lot or on any bioflo picc catheters for print issues in the past 15 months, with the exception of the reporting hospital.Four used samples with various stages of print/markings removal were returned.The samples were wiped with a lint free wipes saturated with saline and minimal print removal was noted.It was then wiped with a lint free wipe saturated with 70% isopropyl alcohol and minimal print removal was noted.When a sample was vigorously scrubbed with a wipe saturated with alcohol approx.30 times, significant print removal was noted.When the same exercise was conducted with a saline saturated wipe, no print removal was noted.Unused samples were also returned.They were subjected to angiodynamics' print integrity testing, and passed.For all catheters, print removal could only be achieved after multiple/aggressive wiping of the catheters.It should be noted that in no instance was the print completely removed, it was only lightened.The root cause of the catheter ink coming off as observed by the end user could not be definitively determined based on the sample review.Potential contributing factors could be patient anatomy/blood chemistry.(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: 8624571
• Report Number: 1317056-2019-00068
• Device Sequence Number: 19421616
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: 01/31/2021
• Device Catalogue Number: H965458110
• Device Lot Number: 5422563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1