MAUDE Adverse Event Report: BARD ACCESS SYSTEMS S/L PERC 8FR 65D; CENTRAL VENOUS CATHETER

Model Number	7711800
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
One of the devices has been returned to the manufacturer for evaluation.The devices for the other two malfunctions were not returned; therefore, they are inconclusive for having a defective component.He investigation for the malfunction with the returned device is currently underway.The device is labeled for single use.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model 7711800 central venous catheter allegedly had defective components.This information was received from various sources.The malfunctions involved patients without consequence.Two malfunctions involved a patient that was a (b)(6) year old female weighing (b)(6) kgs.The third malfunction involved a (b)(6) year old female weighing (b)(6) kgs.
Additional Manufacturer Narrative
Of the 3 devices, 2 lot numbers were provided, and lot history reviews were performed.Of the 3 reported malfunctions, defective component were confirmed for 2 devices.1 sample was sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Of the 3 devices, the product catalog number of 1 device was updated to unknown.A root cause has not been determined.The devices were labeled for single use.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model 7711800.Central venous catheter allegedly had defective components.These reports were received from various sources.All three events had no reported patient injury.The malfunctions involved patients without consequence.Three patients age ranged from 17-44 years, females, and weight ranged from 37-102 kgs.

• Brand Name: S/L PERC 8FR 65D
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8822398
• Report Number: 3006260740-2019-02167
• Device Sequence Number: 19589914
• Product Code: LJS
• UDI-Device Identifier: 00801741036743
• UDI-Public: (01)00801741036743
• 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): 10/10/2019

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: 7711800
• Device Catalogue Number: 7711800
• Device Lot Number: REDN2519, UNKNOWN
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 10/10/2019
• Patient Sequence Number: 1