MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 9.5 FR DUAL LUMEN CATHETER, 5 CM CUFF LOCATION, MICRO KIT; CHRONIC CATHETER

Model Number	0805915
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was not returned, however a photo was provided for review.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 indicated that model 0805915 chronic catheter allegedly experienced a defective component.This information was received from one source.One patient was involved and there was no reported patient injury.The patient's age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the device was not returned for the reported malfunction.One electronic photo was returned for evaluation.A lot history review was no performed, as the lot number was not provided.The evaluation was inconclusive for the reported defective component due to the lack of objective evidence of a deficiency with the in-growth cuff.A definitive root cause could not be determined.The device is labeled for single use.H10: g4 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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0805915 chronic catheter allegedly experienced a defective component.This information was received from one source.One patient was involved and there was no reported patient injury.The patient's age, weight, and gender were not provided.

• Brand Name: 9.5 FR DUAL LUMEN CATHETER, 5 CM CUFF LOCATION, MICRO KIT
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9209551
• Report Number: 3006260740-2019-03162
• Device Sequence Number: 14190666
• Product Code: LJS
• UDI-Device Identifier: 00801741036699
• UDI-Public: (01)00801741036699
• 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): 01/07/2020

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: 0805915
• Device Catalogue Number: 0805915
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 01/07/2020
• Patient Sequence Number: 1