MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. REPAIR,WHITE ADAPTER LEG; CENTRAL VENOUS CATHETER

Model Number	0601680
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.As received, one hickman repair kit sealed in packaging.Foreign material was noted on the inner packaging.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that foreign material was allegedly found in the packaging of a model 0601680 central venous catheter.This information was received from a single source.There was no patient contact.The patient age, weight, and gender were not provided.

• Brand Name: REPAIR,WHITE ADAPTER LEG
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8801018
• Report Number: 3006260740-2019-02002
• Device Sequence Number: 16198468
• Product Code: LJS
• UDI-Device Identifier: 00801741036415
• UDI-Public: (01)00801741036415
• 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
• Report Date (Section B): 07/17/2019

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: 0601680
• Device Catalogue Number: 0601680
• Device Lot Number: REDN1374
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/17/2019
• Patient Sequence Number: 1