MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT ISP MRI, 6.0 FR, INT., CHRONOFLEX, OPEN; IMPLANTABLE PORT

Model Number	1806061
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
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 was performed.The device has been 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 1806061 implantable port allegedly experienced a fracture.This information was received from one source.This malfunction did involve a patient with no consequences.The male patient's age, and weight were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 1806061 implantable port allegedly experienced a fracture.This information was received from one source.This malfunction did involve a patient with no consequences.The male patient's age, and weight were not provided.
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.The investigation is confirmed for catheter break issue and wear issue.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H11: 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.
Additional Manufacturer Narrative
H10: the initial mdr submitted for this malfunction inaccurately reported the mdr date of awareness.The correct mdr date of awareness is (b)(6) 2020.H10: the lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation.The company is still investigating the issue at this time.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 1806061 implantable port allegedly experienced a fracture.This information was received from one source.This malfunction did involve a patient with no consequences.The male patient's age, and weight were not provided.
Additional Manufacturer Narrative
H10: the initial mdr submitted for this malfunction inaccurately reported the mdr date of awareness.The correct mdr date of awareness is (b)(6)2020.H10: the lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.H10: g4, h2 h11: g1 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 1806061 implantable port allegedly experienced a fracture.This information was received from one source.This malfunction did involve a patient with no consequences.The male patient's age, and weight were not provided.

• Brand Name: POWERPORT ISP MRI, 6.0 FR, INT., CHRONOFLEX, OPEN
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9963908
• Report Number: 3006260740-2020-01320
• Device Sequence Number: 2785110
• Product Code: LJT
• UDI-Device Identifier: 00801741026959
• UDI-Public: (01)00801741026959
• 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,Followup
• Report Date (Section B): 10/08/2020

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: 1806061
• Device Catalogue Number: 1806061
• Device Lot Number: REDP0431
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 04/21/2020; 06/25/2020; 09/30/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 04/21/2020; 07/09/2020; 10/08/2020
• Patient Sequence Number: 1