MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 200CC CLOSED WOUND SUCTION SILICONE EVACUATOR; SUCTION EVACUATOR

Catalog Number 0071200

Device Problems Disconnection (1171); 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 Date 03/10/2020

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 cap came off.

Manufacturer Narrative

The reported event was unconfirmed since the reported failure could not be reproduced.Visual evaluation of the returned sample noted one opened (without original packaging), 200cc silicone bulb evacuator.Visual inspection of the sample noted no obvious visible defects.On sample receipt, the tethered cap was connected to the port and remained in place without interference.The cap was then removed without issue.Both ports were able to be closed firmly and the caps were abled to be removed with moderate force (approx.5 lbs).No other damages or missing components were noted.This is within specification per inspection procedure which states, "no damaged or missing components." 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: indications for use: wound drains are used to remove exudates from wound sites.A.Drain placement for 100cc, 200cc, and 400cc silicone evacuators 1.Place wound drain(s) within critical fluid collection areas.2.Draw non-perforated section of wound drain through skin until drain indicator mark appears at the skin surface.3.Attach non-perforated section of drain directly to evacuator inlet port.4.200cc and 400cc silicone evacuators: when using 2 silicone drains with one evacuator, clip sealed inlet port and attach second drain.B.Drain placement for all other evacuators 1.Place wound drain(s) within critical fluid collection areas.2.Draw non-perforated section of wound drain through skin until drain indicator mark appears at the skin surface.3.Attach non-perforated section of drain either to y-connector or directly to evacuator inlet port.4.With two silicone drains, attach blue adaptors to drains and y-connector, and attach y-connector to inlet port.Note: for 1/8¿ (3.2 mm) round drain, y-connector or enclosed 1/8¿ (3.2 mm) drain adapter must be used to connect to evacuator.Caution: do not puncture or perforate drain.C.With silicone round double drain 1.See instructions with drain.D.Attaching to auxiliary suction 1.Connect suction tube to empty port using a stepped 5-in-1 connector.2.During auxiliary suction, evacuator will deflate and exudate will flow through evacuator into suction tube.E.To establish suction 1.Open empty port.2.Squeeze evacuator.3.Close empty port.Note: reflux of fluid to the patient is minimized during reactivation by an anti-reflux valve in inlet port.F.To empty container 1.Open empty port over collection basin.2.Squeeze evacuator to empty.G.To re-establish suction 1.Repeat step ¿e¿ above.H.To read fluid volume 1.Invert unit.2.Open empty port to release vacuum.3.Read and record approximate volume.4.Empty and reactivate evacuator." 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.

Event Description

It was reported that the cap came off.

• Brand Name: 200CC 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: 9866336
• MDR Text Key: 186548740
• Report Number: 1018233-2020-02024
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741049637
• UDI-Public: (01)00801741049637
• 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: 05/07/2020

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 Catalogue Number: 0071200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Initial Date Manufacturer Received: 03/01/2020
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: 05/04/2020
• Supplement Dates FDA Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1