MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MRI L/P PORT W/GROS 7.0F; IMPLANTABLE PORT

Model Number	0603870
Medical Device Problem Codes	Defective Component (2292); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has not been returned for evaluation, but a photo has been returned for evaluation.The investigation of the reported malfunction is currently underway.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0603870 implantable port allegedly experienced defective components.This information was received from one source.The malfunction involved one patient with no patient consequences.The (b)(6) year old male patient weighed (b)(6).
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review will be performed.The device and a photo has been returned for evaluation.The investigation of the reported malfunction is currently underway.The device is labeled for single use.H11: h6(method).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 0603870 implantable port allegedly experienced defective components.This information was received from one source.The malfunction involved one patient with no patient consequences.The 61 year old male patient weighed 63 kilograms.
Additional Manufacturer Narrative
H10: the lot number was provided, therefore a lot history review was performed.The sample was returned as well as photos were provided and the investigation is confirmed for deformed dilator tip and bent guide wire.The definitive root cause could not be determined based upon available information.The device was labeled for single use.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 0603870 implantable port allegedly experienced defective components.This information was received from one source.The malfunction involved one patient with no patient consequences.The 61 year old male patient weighed 63 kilograms.

• Brand Name: MRI L/P PORT W/GROS 7.0F
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9593807
• Report Number: 3006260740-2020-00115
• Device Sequence Number: 2474391
• Product Code: LJT
• UDI-Device Identifier: 00801741025839
• UDI-Public: (01)00801741025839
• 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,Followup
• Report Date (Section B): 06/30/2020

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: 0603870
• Device Catalogue Number: 0603870
• Device Lot Number: RECQ0183
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/24/2020; 06/29/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 04/02/2020; 06/30/2020
• Patient Sequence Number: 1