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

Model Number 0070740

Device Problem Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2022

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 after the suction evacuator was squeezed, it did not recover from the deflated state and could not be aspirated.

Manufacturer Narrative

The reported event was confirmed cause unknown.1sample were confirmed to exhibit the reported failure.The device had not met specifications.It is unknown if the product was used for patient treatment.The product caused the reported failure.A potential root cause for this failure mode could be ¿interface between the bulb and bulb cap is compromised (cap is loose; cap was not assembled properly to the bulb".The device history record review could not be performed without a lot number.The investigation is concluded, and no additional action is required at this time.The instructions for use were found adequate and state the following: warnings: 1.An effective closed suction drain system requires maintenance of the system to preserve patency.The drain must not be allowed to occlude nor the reservoir to completely fill; and reservoir must be maintained in order for the system to function properly.If the system is not maintained properly, surgical complications including hematomas may result.Instructions for use: 1.The surgeon should irrigate the wound with sterile fluid and then suction the irrigating fluid and gross debris from the operative site.2.Tubes should lie flat and in line with the anticipated skin exit.To facilitate later removal by manual traction, the tubing should not be curled, pinched, or sutured internally.3.Positioning of the drain in the body cavity, as well as the number of drains indicated, should be determined by the surgeon.4.Drain tubing should be placed within the wound by approximating the areas of critical fluid collection.5.Care must be taken to ensure that all drain perforations or channels lie completely within the wound or cavity to be drained.6.Taping or a triple loop suture (around and not through the tubing) will aid in preventing accidental drain placement.7.Deep drainage is best accomplished by using one or more drains for each level of tissue.Each level should be evacuated by a separate vacuum source.8.Care must be exercised to avoid damage to the drain (refer to warnings).The tubing should be repeatedly checked during closure for free motion to avoid breakage and/or fragment retention within the wound.9.When using a trocar please follow these instructions: 9.I.) with one drain: draw drain using trocar from inside to outside of wound.Ensure that perforated section of the drain is within the critical fluid collection areas of wound.Remove trocar only by cutting the drain one inch from the end of the trocar.Trim non-perforated section of drain to desired length.Attach non-perforated section of drain either to an evacuator inlet port or to a y-connector.9.Ii.) with two single drains: follow instruction # 9.I for each of the two drains separately.9.Iii.) with a double drain: draw drain using trocar from inside to outside of wound.Ensure that desired perforated region of the drain is within the critical fluid collection areas of wound.Cut the outer portion of the drain (outside the wound area) in the middle of the perforated region.Attach non-perforated section of the inserted drain to an evacuator inlet port or to ay-connector.After cutting (as mentioned above), the second half of this drain can be used separately.If you are not using the second half then dispose of it as per the hospital protocol.10.Attaching to auxiliary suction: 10.I.) connect suction tube to empty port using a stepped 5-in-1 connector.10.Ii.) during auxiliary suction evacuator will deflate and exudates will flow through evacuator into suction tube.11.To establish suction: 11.I.) open empty port.11.Ii.) squeeze evacuator.11.Iii.) close empty port.Note: reflux of fluid to the patient is minimized during reactivation by an anti-reflux valve in inlet port.12.To empty container: 12.I.) open empty port over collection basin.12.Ii.) squeeze evacuator to empty.13.To re-establish suction: repeat step 11 above.14.To read fluid volume: 14.I.) invert unit.14.Ii.) open empty port to release vacuum.14.Iii.) read and record approximate volume.14.Iv.) empty and reactivate evacuator.H11: section a through f - the information provided by bd represents all 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 actual/suspected device was inspected.

Event Description

It was reported that after the suction evacuator was squeezed, it did not recover from the deflated state and could not be aspirated.

• Brand Name: CLOSED WOUND SUCTION
• Type of Device: CLOSED WOUND SUCTION
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15888017
• MDR Text Key: 307711445
• Report Number: 1018233-2022-09135
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741049569
• UDI-Public: (01)00801741049569
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

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
• Device Operator: Health Professional
• Device Model Number: 0070740
• Device Catalogue Number: 0070740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other