MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 WOUND DRAINAGE; UNKNOWN ROUND WOUND DRAIN

Catalog Number UNKNOWN

Device Problems Partial Blockage (1065); Complete Blockage (1094); Suction Failure (4039)

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

Event Date 10/18/2018

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 device was difficult to suction during surgery.Per additional information received from sample evaluation from investigators on 18-jan-2019, the round wound drain attached to the evacuator was blocked.

Manufacturer Narrative

The reported event was confirmed.Visual evaluation of the returned sample noted one opened (no original packaging present), reliavac evacuator connected to a round wound drain.Concomitant, in-house evacuator tubing was attached to port a of the evacuator.The other end of the tubing was placed in a reservoir of 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 negative pressure.The device did not suction any water.After the wound drain was removed, the evacuator suctioned 400cc of solution as intended.The wound drain was dissected to reveal blood and tissue blocking the channels.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product family is unknown, the wound drainage product ifus are found to be adequate based on past reviews.

Event Description

It was reported that the device was difficult to suction during surgery.

• Brand Name: WOUND DRAINAGE
• Type of Device: UNKNOWN ROUND WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8322077
• MDR Text Key: 138816280
• Report Number: 1018233-2019-00712
• Device Sequence Number: 1
• Product Code: GCY
• 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: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2018
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1