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)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample has been returned for evaluation.The investigation has identified a break in the catheter.The root cause has not been determined.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 0603840, implantable port, allegedly experienced a break in the catheter.This information was obtained from a single source.This malfunction involved a five year old female patient with no consequences, the patient's weight was not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0603840, implantable port, allegedly experienced a break in the catheter.This information was obtained from a single source.This malfunction involved a five year old female patient with no consequences, the patient's weight was not provided.
Additional Manufacturer Narrative
H10: the lot number was not provided and a lot history review could not performed.The sample has been returned for evaluation.The investigation has confirmed for a break, fracture, material separation, fluid leak, and material split/cut/torn.The root cause has not been determined.The device was labeled for single use.H10: g4,h2.H11: h6 (device code material split, cut or torn - 2537/2454/3024/4008, fluid leak - 1250).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: 9208942
• Report Number: 3006260740-2019-03140
• Device Sequence Number: 449368
• 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): 03/30/2020

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: 09/30/2019
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1