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

Model Number 0070800

Device Problems Inflation Problem (1310); Suction Problem (2170)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that it was difficult to inflate and suction.Per additional information received via mail from ibc on 28jul2020, there were no visible damage to the catheter.Per additional information received via mail from ibc on 29jul2020, it was difficult to inflate the balloon and it was difficult to suction.

Event Description

It was reported that it was difficult to inflate and suction.Per additional information received via mail from ibc on 28jul2020, there were no visible damage to the catheter.Per additional information received via mail from ibc on 29jul2020, it was difficult to inflate the balloon and it was difficult to suction.

Manufacturer Narrative

The reported event was unconfirmed since the problem could not be reproduced.An evacuator was returned.No visible balloon damage was noted.Evacuator balloon was able to be fully inflated without issue.The lot number was unknown; therefore, the device history record could not be reviewed.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." 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.

• Brand Name: RELIAVAC 400 EVACUATOR, 400ML CAPACITY, Y-CONNECTING TUBE, 35" (88.9CM) STERILE
• Type of Device: RELIAVAC EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10397638
• MDR Text Key: 203502883
• Report Number: 1018233-2020-05120
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741049606
• UDI-Public: (01)00801741049606
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0070800
• Device Catalogue Number: 0070800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1