MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MRI L/P PORT W/GROS 7.0F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0603870
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device for this event has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 603870 port & catheter allegedly had an improper or incorrect procedure or method.This information was received from one source.The malfunction involved a patient without consequence.
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation identified an improper or incorrect procedure or method.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.Pma/510k.(results, conclusion.).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 603870 port & catheter allegedly had an improper or incorrect procedure or method.This information was received from one source.The malfunction involved a patient without consequence.The patient age, weight, and sex were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 603870 port & catheter allegedly had an improper or incorrect procedure or method.This information was received from one source.The malfunction involved a patient without consequence.The patient age, weight, and sex were not provided.
Additional Manufacturer Narrative
H10: the previous supplemental mdr was submitted on time but with an incorrect g4 date, therefore this supp is being sent to correct the mdr date of awareness.H10: g4 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/GROS 7.0F
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8818064
• Report Number: 3006260740-2019-02113
• Device Sequence Number: 14278789
• 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): 11/07/2019

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: REBX1612
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 06/30/2019; 11/06/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 10/18/2019; 11/07/2019
• Patient Sequence Number: 1