MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SURGICAL SHUNT; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	SGA150001
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event for material erosion is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the event indicated that model sga15001 vascular, cardiopulmonary bypass shunt alleged that the paint on the shunt came off, and was left inside of the patient.This report was received from one source.The event involved a patient with no known impact to the patient.The patients age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event for material erosion is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.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 event indicated that model sga15001 vascular, cardiopulmonary bypass shunt alleged that the paint on the shunt came off, and was left inside of the patient.This report was received from one source.The event involved a patient with no known impact to the patient.The patients age, weight, and gender were not provided.

• Brand Name: SURGICAL SHUNT
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8805210
• Report Number: 2020394-2019-01604
• Device Sequence Number: 320261
• Product Code: DWF
• UDI-Device Identifier: 00801741090219
• UDI-Public: (01)00801741090219
• 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): 10/22/2019

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: SGA150001
• Device Catalogue Number: SGA150001
• Device Lot Number: HUCX0313
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 10/22/2019
• Patient Sequence Number: 1