MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SILICONE FLAT DRAIN; WOUND DRAIN

Catalog Number	0070360
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
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.Udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that there was a frayed edge on the tip of the wound drain, the side that was left inside the body.There was damage to the tip of the drain.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Received (5) photo samples.First photo sample shows an overview of hubless silicone flat drain.Second photo sample zooms in on sideview of end of hubless silicone flat drain.Third and fourth photo sample shows hubless silicone flat drain with loose pieces of silicone.Fifth photo sample shows outer tray packaging.Visual evaluation of the returned sample noted one opened (with original packaging), used hubless silicone flat drain.Visual inspection of the sample noted loose pieces of silicone found on the side of the flat drain.This does not meet specification which states "no damaged or missing components".No actions can be taken at this time since a root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and states the following: indications for use: wound drains are used to remove exudates from wound sites.Contraindications: do not use for chest drainage.Warning: do not bypass/inactivate anti-reflux valve.Check for fluid entering reliavac evacuator.Lack of flow may indicate: all exudate has been removed.Wound drain is clogged and may require irrigation and aspiration (consult physician).Auxiliary wall suction pressure is above 210mm hg.Deflated balloon: check all connections for air leak and wound tube perforations for exposure above the skin.If still deflated, replace evacuator.When not using auxiliary suction during surgical wound closure, several activations of the reliavac evacuator may be required to establish suction because of air entering partially closed wound.An operative air pocket.C.Insert safety pin into hole in collar to attach evacuator to patient's clothing or bed linen.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.To avoid the possibility of a hematoma due to wound evacuation, the instructions for use should be carefully followed.To avoid the possibility of drain damage or breakage: additional perforations should not be made in the drains.Avoid suturing through drains.Drains should lie flat and in line with the skin exit areas.Particular care should be taken to avoid any obstacles to the drain exit path.Drains should be checked during closure for free motion to avoid possibility of breakage.Drain removal should be done gently by hand.They should not be handled with pointed, toothed or sharp instruments which could cause cuts or nicks and lead to subsequent structural failure of the drain.Warning: surgical removal may be necessary if drain is difficult to remove or breaks.A.Use with single flat drain 1.Place perforated wound drain within critical fluid collection area of wound.2.Draw drain tube through skin or stab wound incision until flat portion of drain is seated appropriately.3.Trim drain tube to desired length and attach to blue adapter.Connect other end of blue adapter to y-connector.4.Insert connecting tube in reliavac port a, up to indicator ring.B.Use with two flat drains 1.Place perforated portion of wound drains within critical fluid collection areas of wound.2.Draw drain tubes through skin or stab wound incision until flat portion of the drains are seated appropriately.3.Trim drain tubes to desired length.4.Cut off plug from closed arm of y connector and attach blue adapters.5.Attach drains to blue adapters.6.Insert connecting tube in reliavac port a, up to indicator ring.Caution: punctures or additional perforations should not be made in the silicone wound drain.C.Attaching to auxiliary suction 1.Insert suction adapter into port b.2.During auxiliary suction, balloon will inflate and exudate will flow over balloon surface from port a to port b.3.To discontinue auxiliary suction, remove suction adapter and close port b.Caution: do not use with wall suction in excess of 210mm hg.D.To establish suction 1.Open port b.2.Pump bulb until balloon fills container.3.Close port b.Note: hissing sound is normal and stops when maximum suction pressure is reached.Possible reflux of fluid to the patient is reduced during reliavac evacuator reactivation by a built-in anti-reflux valve in port a.E.To empty container 1.Open port b.2.Invert unit.3.Pump bulb to empty quickly.F.To re-establish suction 1.Repeat step dabove.G.To read fluid volume - 1.Open port b.2.Allow balloon to deflate.3.Read and record volume.4.To reactivate, repeat step d udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that there was a frayed edge on the tip of the wound drain, the side that was left inside the body.There was damage to the tip of the drain.

• Brand Name: SILICONE FLAT DRAIN
• Common Device Name: WOUND DRAIN
• 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 20878931
• Report Number: 1018233-2024-07850
• Device Sequence Number: 15416627
• Product Code: GBX
• UDI-Device Identifier: 00801741090738
• UDI-Public: (01)00801741090738(11)240524(17)290331(10)NGJR3258
• 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: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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 Catalogue Number: 0070360
• Device Lot Number: NGJR3258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown