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

Model Number	0603870
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
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 will be performed.The device has not been returned for evaluation, therefore, the investigation is inconclusive for difficult to insert and material deformation as no objective evidence has been provided to confirm any alleged deficiency with the device.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 difficult to insert and material deformation.This information was received from one source.This malfunction involved one patient with no consequences.The weight of the (b)(6) female was (b)(6).
Additional Manufacturer Narrative
H10: the lot number was provided, therefore a lot history review was performed.The sample was not returned and the investigation inconclusive for difficult to insert catheter.A definite root cause for the reported event could not be determined.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 difficult to insert and material deformation.This information was received from one source.This malfunction involved one patient with no consequences.The weight of the 35 year old female was 51 kgs.
Additional Manufacturer Narrative
H10: the lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was returned to the manufacturer for evaluation, however the photo was provided and reviewed.The investigation is confirmed for material deformation and is inconclusive for difficult to insert.A definite root cause for the reported event could not be determined.The device is labeled for single use.H11: h6 (method, results).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 difficult to insert and material deformation.This information was received from one source.This malfunction involved one patient with no consequences.The weight of the 35 year old female was 51 kgs.

• 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: 9959085
• Report Number: 3006260740-2020-01279
• Device Sequence Number: 2377780
• 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): 01/14/2021

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: REDN1592
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/25/2020; 12/31/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 07/10/2020; 01/14/2021
• Patient Sequence Number: 1