MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MRI L/P PORT W/BROV 6.6F; IMPLANTABLE PORT

Model Number	0603840
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Separation (1562); Dent in Material (2526)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number was not provided, a lot history review will not be performed.One device and one electronic photo were returned for evaluation.The investigation identified a complete circumferential elliptically shaped break was noted approximately 5.3cm from the distal end of the cath-lock.A root cause could not be determined.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.The information reviewed indicated that model 0603840 implantable port allegedly experienced a break.This information was received from one source.The malfunction involved a patient with no reported consequences.The male patient's age and weight were not provided.
Event or Problem Description
This report summarizes one malfunction.The information reviewed indicated that model: 0603840 implantable port allegedly experienced a break, dent in material, material separation, and fracture.This information was received from one source.The malfunction involved a patient with no reported consequences.The 67 year old male patient's weight was not provided.
Additional Manufacturer Narrative
H10: as the lot number was not provided, a lot history review will not be performed.One device and one electronic photo were returned for evaluation.The investigation identified a complete circumferential elliptically shaped break was noted approximately 5.3cm from the distal end of the cath-lock.A fracture, dent in material, and material separation were confirmed during the evaluation.A root cause could not be determined.The device is labeled for single use.H11: b5, h6 (device code).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.

• Brand Name: MRI L/P PORT W/BROV 6.6F
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9592520
• Report Number: 3006260740-2020-00100
• Device Sequence Number: 16272622
• Product Code: LJT
• UDI-Device Identifier: 00801741025822
• UDI-Public: (01)00801741025822
• 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): 04/02/2020

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: 0603840
• Device Catalogue Number: 0603840
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 04/02/2020
• Patient Sequence Number: 1