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

Catalog Number 0070800

Device Problems Break (1069); Burst Container or Vessel (1074)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the inner balloon on the reliavac broke.

Event Description

It was reported that the inner balloon on the reliavac broke.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to the ¿dimensions of bladder are not to specification".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "note: do not use with wall suction in excess of 210mm hg" and "pump bulb until balloon fills container".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 device was not returned.

• Brand Name: RELIAVAC 400 EVACUATOR, 400ML CAPACITY, Y-CONNECTING TUBE, 35" (88.9CM) STERILE
• Type of Device: WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9733426
• MDR Text Key: 183956842
• Report Number: 1018233-2020-01213
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 0070800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1