MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ABRAMSON TRIPLE LUMEN SUMP DRAIN WITH FILTER; ABRAMSOM SHEATH SUMP

Catalog Number 0080400

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

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 drain slid out through the flange.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿loose adapter¿ with a potential root cause of ¿drain id out of 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: ¿irrigating the drain in an attempt to keep the sump drain itself patent, surgeons often set up a drip irrigation to cleanse the drain material.Irrigate with sterile saline through the irrigation port.Drain remains connected to auxiliary suction.Irrigating the wound area occasionally, surgeons choose to introduce medication to the wound area or to perform a peritoneal lavage.If so, do the following: 1.Disconnect suction.2.Cap filter vent and suction port.3.Introduce irrigant through irrigation port.4.To re-establish sump action, remove caps from suction and air vent lumens.Reconnect to suction source.Turn on suction.5.If irrigating, uncap irrigating lumen and connect to irrigant.4.Turn on suction.Set at mid-range, 90mm-110mmhg.1.Uncap center lumen.2.Uncap air vent lumen.1.If irrigating, turn flow gauge to off position 5.Disconnect center lumen from suction tubing.Cap center lumen.2.If disconnecting, cap irrigating 3.Turn off suction.4.Cap air vent lumen.Lumen.Drain placement during surgery 1.Position sump drain.Slide suture cuff to skin.Suture in place.2.Tape suture cuff to sump drain.Do not crimp lumens.3.Connect to suction.1.Make sure the suction is set in the mid-range.The filter is not necessarily clogged because it is wet! to check for filter patency, implement the following: 2.Place your finger over the uncapped filter vent.4.If the filter is clogged, replace it with a new sump drain filter (ref 0080500).3.Remove your finger and listen.If the filter is not clogged, you will hear a slight hiss.Abramson triple lumen sump drains gravity drainage - sheath sump drain after termination of applied suction through the abramson sheath sump drain (ref 0080450), surgeons may wish to convert the drain to a silicone gravity drain.To convert the silicone sheath sump to a gravity drain: 1.Cut off drain hub.2.Remove inner sump lumens.3.Silicone sheath now serves as a gravity drain." 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.

Event Description

It was reported that the drain slid out through the flange.

• Brand Name: ABRAMSON TRIPLE LUMEN SUMP DRAIN WITH FILTER
• Type of Device: ABRAMSOM SHEATH SUMP
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8776090
• MDR Text Key: 150744798
• Report Number: 1018233-2019-03791
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741050077
• UDI-Public: (01)00801741050077
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,study
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0080400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1