MAUDE Adverse Event Report: ANGIODYNAMICS SMART PORT; PORT & CATHETER, IMPLANTED

Model Number	CT66LTPD
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem 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: when preparing for a port placement procedure, it was noted the sterile kit packaging contained a hole/puncture, compromising the sterility of the packaged devices.The kit was set aside and a new of te same was used to complete the procedure.It was reported the defective disposable device is available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
Received one smartport kit of reported lot for evaluation.As received, the smartport kit outer tray tyvek lid was damaged (hole in tyvek) as reported by the customer.No holes or damage were noted to the tray, internal package or components.As the internal tray package was undamaged, the devices within the inner tray (e.G.Port) is still considered to be sterile.Based on the sample evaluation, this reported issue does not meet the criteria of a reportable event.This report is being submitted to close out the complaint file.The customer's reported complaint description is confirmed for exterior tray lid damaged.No holes or damage were noted to the internal tray package or components; port device is still sterile.Dhr review of the packaging lot revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Although we are unable to definitively determine an exact root cause for this complaint, the most likely root causeis handling damage after leaving the angiodynamics facility.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: SMART PORT
• Common Device Name: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 9617310
• Report Number: 1317056-2020-00013
• Device Sequence Number: 14122583
• Product Code: LJT
• UDI-Device Identifier: H787CT66LTPD0
• UDI-Public: H787CT66LTPD0
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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: 05/31/2021
• Device Model Number: CT66LTPD
• Device Catalogue Number: H787CT66LTPD0
• Device Lot Number: 5349666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1