MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MRI HARD B ATT OPEN 9.6; IMPLANTABLE PORT

Model Number	0604550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, lot number was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.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 0604550.Implantable port allegedly experienced a break.This report was received from a single source.This event did involve patient with no patient consequences.The patient is (b)(6) years of age, the gender is female, and the weight is (b)(6).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model: 0604550.Implantable port allegedly experienced a break.This report was received from a single source.This event did involve patient with no patient consequences.The patient is 67 years of age, the gender is female, and the weight is 110 lbs.
Additional Manufacturer Narrative
H10: for the reported malfunction, lot number was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation, therefore, the investigation of the reported event is inconclusive, however, medical records were provided for review.The review of the medical records is inconclusive for catheter break.Based upon the available information, the definitive root cause for this event is unknown.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.

• Brand Name: MRI HARD B ATT OPEN 9.6
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9594154
• Report Number: 3006260740-2020-00118
• Device Sequence Number: 667328
• Product Code: LJT
• UDI-Device Identifier: 00801741025860
• UDI-Public: (01)00801741025860
• 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 a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 0604550
• Device Catalogue Number: 0604550
• Device Lot Number: REZF1799
• 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