MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CLOSED WOUND SUCTION 100ML SILICONE EVACUATOR, HUBLESS SILICONE FLAT DRAIN, 7MM; SILICONE BULB WOUND DRAIN

Catalog Number 0071360

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2018

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 there were several black specks embedded into the packaging and the device.

Event Description

It was reported that there were several black specks embedded into the packaging and the device.

Manufacturer Narrative

The reported event was confirmed.Visual evaluation of the returned sample noted one 100cc silicone bulb evacuator with a silicone flat drain within opened original packaging.It was noted that there were loose black specks, one on the inside of the packaging (0.10 sq mm) and one on the outside of the bulb (0.15 sq mm).Foreign matter of greater than an aggregate total area of 0.6 sq mm is out of specification.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: ¿a.Drain placement 1.Place wound drain(s) within critical fluid collection areas.2.Draw non-perforated section of wound drain through skin until flat portion of drain is seated appropriately or drain indicator mark appears at the skin surface.3.Attach non-perforated section of drain either to davol® "y"-connector or directly to evacuator inlet port.Note: (1) since the 1/8" silicone round drain cannot connect directly to the evacuator inlet port, davol #0070780 "y"-connector must be used to connect to evacuator.(2) when using two drains, the davol #0070790 "y"-connector must also be used with 3/16", 1/4" silicone round drains and 7, 10 and 12.7mm silicone flat drains.4.With two silicone drains; cut off plug from closed arm of "y"- connector.Attach both drains to "y"-connector and then attach "y"-connector to inlet port.Caution: do not puncture or perforate drain.B.To establish suction in evacuator 1.Open capped port.2.Squeeze evacuator.3.Close empty port.Orient plug strap so that plug tab does not contact inlet port.C.To empty container 1.Open capped port over collection basin.2.Squeeze evacuator to empty.D.To re-establish suction 1.Repeat step "b" above.".

Event Description

It was reported that there were several black specks embedded into the packaging and the device.

Manufacturer Narrative

The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use was found adequate and states the following: "wound drains are used to remove exudates from wound sites.A.Drain placement 1.Place wound drain(s) within critical fluid collection areas.2.Draw non-perforated section of wound drain through skin until flat portion of drain is seated appropriately or drain indicator mark appears at the skin surface.3.Attach non-perforated section of drain either to davol® "y"-connector or directly to evacuator inlet port.Note: (1) since the 1/8" silicone round drain cannot connect directly to the evacuator inlet port, davol #0070780 "y"-connector must be used to connect to evacuator.(2) when using two drains, the davol #0070790 "y"-connector must also be used with 3/16", 1/4" silicone round drains and 7, 10 and 12.7mm silicone flat drains.4.With two silicone drains; cut off plug from closed arm of "y"- connector.Attach both drains to "y"-connector and then attach "y"-connector to inlet port.Caution: do not puncture or perforate drain.B.To establish suction in evacuator 1.Open capped port.2.Squeeze evacuator.3.Close empty port.Orient plug strap so that plug tab does not contact inlet port.C.To empty container 1.Open capped port over collection basin.2.Squeeze evacuator to empty.D.To re-establish suction 1.Repeat step "b" above.Note: reflux of fluid to the patient is minimized during reactivation by a built-in anti-reflux valve on inlet port.E.To read fluid volume 1.Open capped port to release vacuum.2.Read and record approximate volume.3.Empty and reactivate evacuator.Important: a.Check for fluid entering closed wound suction evacuator.Lack of flow may indicate all exudate has been removed.Check all connections for air leaks and wound tube perforations for exposure above skin.B.Several activations of the closed wound suction evacuator may be required to establish suction because of: - air entering partially closed wound.- an operative air pocket.C.The attached strap may be used to secure the evacuator to the patient.Precautions: 1.Avoid suturing through the drains to minimize the possibility of breakage.2.Drains should lie flat and in line with the skin exit path.3.Particular care should be taken to avoid any obstacles to the drain exit path.4.Drains should be checked for free motion during closure to minimize the possibility of breakage during/after removal.5.Drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or blunt instruments which could cause cuts or nicks and lead to subsequent structural failure of the drain.Warning: drain breakage may require surgical removal.".

• Brand Name: CLOSED WOUND SUCTION 100ML SILICONE EVACUATOR, HUBLESS SILICONE FLAT DRAIN, 7MM
• Type of Device: SILICONE BULB WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8028320
• MDR Text Key: 126009069
• Report Number: 1018233-2018-05133
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741049644
• UDI-Public: (01)00801741049644
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 0071360
• Device Lot Number: NGBY3329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Date Manufacturer Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1