MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 RELIAVAC 100 CLOSED WOUND SUCTION EVACUATOR

Catalog Number 0070900

Device Problems Break (1069); Material Fragmentation (1261); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2020

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 the evacuator was found to be broken when the package was open.Per additional information via email from ibc representative on 15jun2020 it was noted that the suction port was broken.

Event Description

It was reported that the evacuator was found to be broken when the package was open.Per additional information via email from ibc representative on 15jun2020 it was noted that the suction port was broken.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.Visual evaluation of the returned sample noted one opened (no original packaging), used silicone bulb evacuator.It was noted that the blue suction port was broken, with the end of the port seeming chipped off.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be defective components received from supplier.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labelling could not have prevented the reported failure.

• Brand Name: RELIAVAC 100 CLOSED WOUND SUCTION EVACUATOR
• Type of Device: SUCTION EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10190208
• MDR Text Key: 196766321
• Report Number: 1018233-2020-04049
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741049620
• UDI-Public: (01)00801741049620
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0070900
• Device Lot Number: NGDU3236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1