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

Catalog Number 0070740

Device Problems Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 08/21/2019

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 user found a dirt inside the bag before he/she opened the package.

Event Description

It was reported that the user found a dirt inside the bag before he/she opened the package.

Manufacturer Narrative

The reported event was confirmed as manufacturing related (loose foreign material).Visual evaluation of the returned sample noted one unopened (in original packaging), 100cc silicone bulb evacuator.Visual inspection of the sample noted a piece of foreign material in the seal of the package and another piece of foreign material loose on the outside of the bulb within the package.The packaging was opened and the foreign material pieces were measured.The piece of material in the seal measured 0.80 sqmm.The piece of material loose on the bulb exterior measured 0.60 sqmm.This is out of specification per inspection procedure which states, "packaging shall be free of loose or embedded foreign matter greater than an aggregate total of 0.6 mm2 or 1/16" in length per the dirt estimation chart.(maximum 3 particles)." a potential root cause for this failure could be, ¿production areas not following cleaning procedure.¿ the device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "vii.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 a y-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.Important: a.Check for fluid entering closed wound suction evacuator.Lack of flow may indicate all exudate has been removed.B.When not using auxiliary suction during surgical wound closure, several activations of the closed wound suction evacuator may be required to establish suction because of the following: i.Air entering partially closed wound.Ii.An operative air pocket.C.The attached strap may be used to secure the evacuator to the patient." 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.

• Brand Name: CLOSED WOUND SUCTION SILICONE EVACUATOR
• Type of Device: SUCTION EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9071128
• MDR Text Key: 184461754
• Report Number: 1018233-2019-05658
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741049569
• UDI-Public: (01)00801741049569
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 0070740
• Device Lot Number: NGCV1577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1