MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT MRI ISP 9.6 FR. SILICONE SINGLE LUMEN CATHETER; IMPLANTABLE PORT

Model Number	1859660
Medical Device Problem Code	Fracture (1260)
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 for this malfunction has been returned to the manufacturer for evaluation.The investigation of the reported malfunction 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 1859660 implantable port allegedly experienced fracture.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review will be performed.The device for this malfunction was returned to the manufacturer for evaluation.The evaluation results state that the device was returned with a catheter segment embedded in the catheter.Fracture was identified in the returned device.The definite root cause could not be determined based on the available information.The device is labeled for single use.H11: g1, h6 (results & conclusion).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 1859660 implantable port allegedly experienced fracture.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.

• Brand Name: POWERPORT MRI ISP 9.6 FR. SILICONE SINGLE LUMEN CATHETER
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9941818
• Report Number: 3006260740-2020-01227
• Device Sequence Number: 16868887
• Product Code: LJT
• UDI-Device Identifier: 00801741027222
• UDI-Public: (01)00801741027222
• 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): 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: 1859660
• Device Catalogue Number: 1859660
• Device Lot Number: REDW2827
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/30/2020
• Patient Sequence Number: 1