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

Catalog Number	0070900
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/01/2020
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 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 or Problem 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.
Additional 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
• Common Device Name: SUCTION EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10190208
• Report Number: 1018233-2020-04049
• Device Sequence Number: 2273072
• Product Code: GCY
• UDI-Device Identifier: 00801741049620
• UDI-Public: (01)00801741049620
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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 Expiration Date: 07/31/2024
• Device Catalogue Number: 0070900
• Device Lot Number: NGDU3236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1