MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT CV SLIM SPNB 6 FR CHRONOFLEX SLTH; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	5676300
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned for evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 5676300 port and catheter allegedly experienced a missing component.This information was received from one source.One patient was involved and there was no reported patient injury.Patient information was not provided.
Additional Manufacturer Narrative
H10: the lot number for the reported malfunction was provided and a lot history review was performed.The device was returned and incorrect component was confirmed.The definitive root cause could not be determined.The device is labeled for single use.H10: g4 h11: h6 (results, conclusion) h11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 5676300 port and catheter allegedly experienced a missing component.This information was received from one source.One patient was involved and there was no reported patient injury.Patient information was not provided.

• Brand Name: POWERPORT CV SLIM SPNB 6 FR CHRONOFLEX SLTH
• 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: 9211267
• Report Number: 3006260740-2019-03204
• Device Sequence Number: 449371
• Product Code: LJT
• UDI-Device Identifier: 00801741110771
• UDI-Public: (01)00801741110771
• 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): 01/08/2020

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: No Information
• Device Model Number: 5676300
• Device Catalogue Number: 5676300
• Device Lot Number: RECX3530
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 01/08/2020
• Patient Sequence Number: 1