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

Catalog Number	0071360
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2018
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.The information provided by bard 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 bard.
Event or Problem Description
It was reported that the wound drain was not draining properly.The drain tube was allegedly flushed with 10cc of saline but the compressed bulb did not expand.A flush was used with a stop cock to force fluid into drain, at which time it popped the one way valve flap off drain, which started to drain 30-40 cc bile/effulent.
Additional Manufacturer Narrative
The reported issue (it was reported that the drain had been inserted march 21 and was allegedly not draining.The drain tube allegedly flushed with 10cc freely but compressed bulb jackson pratt drain (jp) did not fill.A flush was used with stop cock to force fluid into jp drain at which time it popped one way valve flap off jp and started to drain 30-40 cc bile/ effluent) was confirmed.During visual evaluation of the photo, it was noted that the duck bill valve was totally disconnected from the bulb.Dimensional evaluation could not be performed due to that no physical sample was returned for evaluation.Only one photo sample was received for investigation.This photo showed a 100cc silicone evacuator product.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿100cc silicone closed wound suction evacuator and silicone drains indications for use: this product is intended for closed wound drainage following head and neck, abdominal, ent, ob/gyn, plastic surgery and neurosurgery.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.".
Event or Problem Description
It was reported that the wound drain was not draining properly.The drain tube was allegedly flushed with 10cc of saline but the compressed bulb did not expand.A flush was used with a stop cock to force fluid into drain, at which time it popped the one way valve flap off drain, which started to drain 30-40 cc bile/effulent.

• Brand Name: CLOSED WOUND SUCTION 100ML SILICONE EVACUATOR, HUBLESS SILICONE FLAT DRAIN
• Common Device Name: SILICONE BULB WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7542379
• Report Number: 1018233-2018-01890
• Device Sequence Number: 1719046
• Product Code: GCY
• UDI-Device Identifier: 00801741049644
• UDI-Public: (01)00801741049644
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2018

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 Expiration Date: 08/31/2022
• Device Catalogue Number: 0071360
• Device Lot Number: NGBV1648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 07/04/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1