MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SMALL VENOUS CATH 6.6F; IMPLANTABLE PORT

Model Number	0602290
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number for the reported malfunction was provided, therefore a lot history review will be performed.The device was not returned for evaluation.Therefore, the investigation will be inconclusive for the reported obstruction of flow issue.The definite root cause could not be determined based on he available information.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model 0602290 implantable port allegedly experienced obstruction of flow.This report was received from one source.One patient was involved with no reported patient injury.The patients¿ age, weight, and gender were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model 0602290 implantable port allegedly experienced obstruction of flow.This report was received from one source.One patient was involved with no reported patient injury.The patients¿ age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: for the reported malfunction, the file was reassessed and determined to be reportable as a serious injury and was reported under emdr number 3006260740-2020-03381.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: SMALL VENOUS CATH 6.6F
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10289027
• Report Number: 3006260740-2020-02514
• Device Sequence Number: 812480
• Product Code: LJT
• UDI-Device Identifier: 00801741025617
• UDI-Public: (01)00801741025617
• 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): 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 0602290
• Device Catalogue Number: 0602290
• Device Lot Number: REDR1991
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 10/20/2020
• Patient Sequence Number: 1