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

Catalog Number	H96560M1406061
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported: there has been a picc malfunction on a line we placed 2 weeks ago.There appears to be a hole in the line that is leaking fluid being administered to the patient.There was no indication the patient was adversely affected by this event.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a 5f bioflo picc.As received, the catheter was contained fluid inside and out.An injection cap (needleless connector) was attached to each hub.A visual inspection upon receipt confirmed the customer's event description of a leak.There was a hole/slice in the oversleeve.This location is indicative of damage to the oversleeve rather than a result of the insert molding of the oversleeve onto the extension tubing.No manufacturing non-conformances or out of specification conditions were observed during sample evaluation.The root cause for this event is handling damage.A potential root cause for the handling damage is tubing cut by scalpel during picc placement procedure or scissors during dressing change.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.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.Complaint # (b)(4).

• 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 12801
• MDR Report Key: 9124789
• Report Number: 1317056-2019-00123
• Device Sequence Number: 2322946
• Product Code: LJS
• UDI-Device Identifier: H96560M1406061
• UDI-Public: H96560M1406061
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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: 12/31/2020
• Device Catalogue Number: H96560M1406061
• Device Lot Number: 5430832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1