MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT TI LOW PROFILE, 6 FR CHRONOFLEX, MI, W/ SUTURE PLUGS, ATTACH.; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1716070
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device for this event has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The device is labeled for single use.
Event or Problem Description
This report summarizes one (1) malfunction event.A review of the event indicated that model 1716070 implantable port experienced a tear, rip, or hole in device packaging.This event was reported from a single source.This event had no reported patient involvement.The patient¿s age, weight, and sex were not provided.
Additional Manufacturer Narrative
The device for this event has been returned to the manufacturer for evaluation.The investigation is confirmed for packaging holes, as the outer seal was received partially peeled form the tray.Damage was observed on one side of the outer tray.The other side was observed to be intact.The proximal end of the tunneler was observed to be protruding from the outer packaging, piercing through both trays.There is no indication that the sterile barrier breach is related to a design failure, as the powerport ti low profile packaging configuration passed ship testing.The definitive root cause for the hole identified in the device packaging could not be determined based on the provided information the device is labeled for single use.
Event or Problem Description
This report summarizes one (1) malfunction event.A review of the event indicated that model 1716070 implantable port experienced a tear, rip, or hole in device packaging.This event was reported from a single source.This event had no reported patient involvement.The patient¿s age, weight, and sex were not provided.

• Brand Name: POWERPORT TI LOW PROFILE, 6 FR CHRONOFLEX, MI, W/ SUTURE PLUGS, ATTACH.
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8533233
• Report Number: 3006260740-2019-01092
• Device Sequence Number: 19200860
• Product Code: LJT
• UDI-Device Identifier: 00801741026768
• UDI-Public: (01)00801741026768
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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: No Information
• Device Model Number: 1716070
• Device Catalogue Number: 1716070
• Device Lot Number: RECZ0666
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1