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
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
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 it was difficult to inflate the balloon of the reliaivac evacuator.
Event or Problem Description
It was reported that balloon of the reliavac evacuator was difficult to inflate.
Additional 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
• Common Device Name: SUCTION EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11607743
• Report Number: 1018233-2021-01813
• Device Sequence Number: 11764723
• 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): Y
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

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 Model Number: 0070800
• Device Catalogue Number: 0070800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other