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

Model Number 0070800

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2021

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 the balloon of the reliaivac evacuator.

Event Description

It was reported that balloon of the reliavac evacuator was difficult to inflate.

Manufacturer Narrative

The reported event was unconfirmed as the problem could not be reproduced.Visual evaluation of the returned sample noted one opened (without original package) used reliavac evacuator with drainage tubing was received.Visual inspection of the sample noted no obvious visible defects.The drainage tubing was attached to port a of the evacuator.The other end of the tubing was placed in a reservoir of methylene blue solution (3 drops 1 percent aqueous methylene blue per 100 ml distilled water).The evacuator balloon was inflated by engaging the bulb at the top of the device.The balloon was fully inflated with no difficulty and port b was closed off to create a negative pressure.The balloon began to deflate and suction solution.The evacuator suctioned water as intended.A potential root cause for this failure mode was unable to determine due to the reported event was unconfirmed.The reported failure was considered as within the specifications.The product was used for treatment.The product did not caused the reported failure.The device history record review was not required due to the reported issue was unconfirmed.The labeling review was not required due to the reported event was unconfirmed.Correction: d, e.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.H3 other text : the actual/suspected device was inspected.

• Brand Name: RELIAVAC 400 EVACUATOR, 400ML CAPACITY, Y-CONNECTING TUBE, 35" (88.9CM) STERILE
• Type of Device: SUCTION EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11607743
• MDR Text Key: 244127126
• Report Number: 1018233-2021-01813
• 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): Y
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• 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: 04/07/2021
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other