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 Problems Gas/Air Leak (2946); Suction Failure (4039)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

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 the air leaked during the suction on the 3rd day after use.

Event Description

It was reported that the air leaked during the suction on the 3rd day after use.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product was used for treatment.The product had not caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used reliavac evacuator with tubing and drain.Visual inspection of the sample noted no obvious visible defects.The drain was placed in a reservoir of methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water).Evacuator balloon was inflated by engaging the bulb at the top of the device.Balloon was fully inflated with no difficulty and port b was closed off to create negative pressure.Balloon began to deflate and suction water.The device suctioned 400cc of water as intended so air leaks do not seem to have occurred.This does meets the acceptance criteria outlined, no root cause could be found because the reported event was unconfirmed.The device was returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.As the reported event is unconfirmed a labeling review is not required.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: 11363043
• MDR Text Key: 233030173
• Report Number: 1018233-2021-00676
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• 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: 02/18/2021
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other