MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DUAL SLIMPORT, 7FR O/E D; IMPLANTABLE PORT

Model Number	0604970
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, lot number was provided, and lot history review.The return of the sample is pending.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0604970.Implantable port allegedly experienced a fracture.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.
Additional Manufacturer Narrative
H.10.The lot number for the malfunction was not provided, therefore the manufacturing review could not be conducted.The device has been returned for evaluation; the investigation is confirmed for a fracture.Based upon the available information, the definitive root cause is unknown.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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0604970.Implantable port allegedly experienced a fracture.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.

• Brand Name: DUAL SLIMPORT, 7FR O/E D
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9205802
• Report Number: 3006260740-2019-03125
• Device Sequence Number: 19590964
• Product Code: LJT
• UDI-Device Identifier: 00801741025884
• UDI-Public: (01)00801741025884
• 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): 01/07/2020

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: 0604970
• Device Catalogue Number: 0604970
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 01/07/2020
• Patient Sequence Number: 1