MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 8.0FR W/-4 VITACUFF PERC; CHRONIC CATHETER

Model Number	7711804
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model 7711804 chronic catheter allegedly experienced a loss or failure to bond.The information was received from one source.There was no patient involved, therefore no patient information was provided.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a lot history review could not be performed.The sample was returned to the manufacturer for inspection/evaluation.Therefore, the investigation is confirmed for the reported loss of or failure to bond, fracture and fluid leak.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: g4.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 indicates that model 7711804 chronic catheter allegedly experienced a loss or failure to bond.The information was received from one source.There was no patient involved, therefore no patient information was provided.

• Brand Name: 8.0FR W/-4 VITACUFF PERC
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9965564
• Report Number: 3006260740-2020-01331
• Device Sequence Number: 19547500
• Product Code: LJS
• UDI-Device Identifier: 00801741036767
• UDI-Public: (01)00801741036767
• 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): 10/06/2020

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: 7711804
• Device Catalogue Number: 7711804
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 10/06/2020
• Patient Sequence Number: 1