MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 RELIAVAC 400 EVACUATOR, 400ML CAPACITY, Y-CONNECTING TUBE, 35" (88.9CM) STERILE; RELIAIVAC SUCTION EVACUATOR

Model Number	0070800
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the reliavac evacuator was difficult to inflate during pretest.
Additional Manufacturer Narrative
The reported event was unconfirmed since the problem could not be reproduced.A reliavac was returned opened without original packaging.The balloon was able to be fully inflated and deflated without issue.The device history record review was not required as the reported event was unconfirmed.The instructions for use were found adequate and state the following: ¿to establish suction: 11.I.) open outlet port.11.Ii.) pump bulb until balloon fills container.11.Iii.) close outlet port.The user guide currently contains instruction that would assist in preventing potential user related causes of reported issue." 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
It was reported that the reliavac evacuator was difficult to inflate during pretest.

• Brand Name: RELIAVAC 400 EVACUATOR, 400ML CAPACITY, Y-CONNECTING TUBE, 35" (88.9CM) STERILE
• Common Device Name: RELIAIVAC SUCTION EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10546832
• Report Number: 1018233-2020-05995
• Device Sequence Number: 11531500
• Product Code: GCY
• UDI-Device Identifier: 00801741049606
• UDI-Public: (01)00801741049606
• 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: distributor,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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: 07/31/2022
• Device Model Number: 0070800
• Device Catalogue Number: 0070800
• Device Lot Number: NGDY0973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1