MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 RELIAVAC 100 CLOSED WOUND SUCTION EVACUATOR, 100ML CAPACITY

Model Number	0070850
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed, however the cause was unknown.Visual inspection noted that one opened 100 cc silicone evacuator was received without the original packaging.Visual evaluation noted that the cap was missing on return.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure mode could be due to incorrect operation of assembly/ positioning of components/ accessories.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labelling review was not performed due to the labeling could not have prevented the reported failure.
Event or Problem Description
It was reported that the cap of the port b in suction evacuator was missing when the package was opened.

• Brand Name: RELIAVAC 100 CLOSED WOUND SUCTION EVACUATOR, 100ML CAPACITY
• Common Device Name: SUCTION EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10920096
• Report Number: 1018233-2020-06364
• Device Sequence Number: 19455311
• Product Code: GCY
• UDI-Device Identifier: 00801741049613
• UDI-Public: (01)00801741049613
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2020

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: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 0070850
• Device Catalogue Number: 0070850
• Device Lot Number: NGDX3497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1