MAUDE Adverse Event Report: BARD ACCESS SYSTEMS KIT TO CHRFX ATT 8FR PEE; IMPLANTABLE PORTS

Model Number	0605320
Medical Device Problem Codes	Fluid/Blood Leak (1250); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided; therefore, a lot history review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.A definitive root cause could not be determined.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 0605320 implantable port allegedly experienced detachment of device and leak.This information was received from one source.This malfunction involved one patient with no consequences.The weight of (b)(6) year old female is (b)(6) kgs.
Additional Manufacturer Narrative
H10: the lot number was provided; therefore, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.A definitive root cause could not be determined.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 0605320 implantable port allegedly experienced detachment of device and leak.This information was received from one source.This malfunction involved one patient with no consequences.The weight of 15 year old female is 75 kgs.

• Brand Name: KIT TO CHRFX ATT 8FR PEE
• Common Device Name: IMPLANTABLE PORTS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10286360
• Report Number: 3006260740-2020-02488
• Device Sequence Number: 2577277
• Product Code: LJT
• UDI-Device Identifier: 00801741025907
• UDI-Public: (01)00801741025907
• 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): 10/19/2020

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: 0605320
• Device Catalogue Number: 0605320
• Device Lot Number: RECQ0494
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 10/19/2020
• Patient Sequence Number: 1