MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MRI HARD B ATT OPEN 9.6; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0604550
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported lot number, the lot number was provided, and lot history review is currently being performed.The sample was returned for evaluation.The company is still investigating the issue at this time.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 0604550 port & catheter, implanted, subcutaneous, intravascular allegedly experienced difficult to insert and break.This report was received from a single source.This event did involve patient with no patient injury.Age, weight, and gender were not provided for the patient.
Additional Manufacturer Narrative
H10: the lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was returned for evaluation.Therefore the investigation is confirmed for the difficult to insert and break.Based upon the available information, the definitive root cause for this event is unknown.The device is 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 0604550 port & catheter, implanted, subcutaneous, intravascular allegedly experienced difficult to insert and break.This report was received from a single source.This event did involve patient with no patient injury.Age, weight, and gender were not provided for the patient.

• Brand Name: MRI HARD B ATT OPEN 9.6
• 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: 9959680
• Report Number: 3006260740-2020-01281
• Device Sequence Number: 19427521
• 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): 10/07/2020

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: 0604550
• Device Catalogue Number: 0604550
• Device Lot Number: REDU3988
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 10/07/2020
• Patient Sequence Number: 1