MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 200CC CLOSED WOUND SUCTION SILICONE EVACUATOR FOR USE WITH ALL BARD CLOSED WOUND; SUCTION EVACUATOR

Catalog Number 0071200

Device Problems Complete Blockage (1094); Suction Problem (2170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2016

Event Type  malfunction  

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.The device was not returned.

Event Description

It was reported that the device was unable to suction on the first day of use.The user said it seemed like something had become stuck or clogged in the device.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: " indications for use: this product is intended for closed wound drainage following head and neck, abdominal, ent, ob/gyn, plastic surgery, cardiothoracic surgery, and neurosurgery.A.Drain placement for 100cc, 200cc, and 400cc silicone evacuators 1.Place wound drains(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 attached second drain.B.Drain placement for all other evacuators 1.Place wound drains(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¿ (3.2mm) round drain, y-connector or, enclosed 1/8¿ (3.2mm) drain adapter must be used to connect to evacuator.Caution: do not puncture or perforate drain.C.With silicone round double 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.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: 1.Air entering partially closed wound.2.An operative air pocket.It is recommended that auxiliary suction be used during surgical closure.C.The attached strap may be used to secure the evacuator to the patient.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Sterilized by ethylene oxide single use caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Precaution: avoid suturing through the drain.Drain 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.Drain should be checked during closure for free motion to avoid possibility of breakage.Drain removal should be done gently by hand.It should not be handled with pointed, tooth 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." (b)(4).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.The device was not returned.

Event Description

It was reported that the device was unable to suction on the first day of use.The user stated that the device was allegedly clogged.

• Brand Name: 200CC CLOSED WOUND SUCTION SILICONE EVACUATOR FOR USE WITH ALL BARD CLOSED WOUND
• Type of Device: SUCTION EVACUATOR
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6393041
• MDR Text Key: 69853975
• Report Number: 1018233-2017-00999
• Device Sequence Number: 1
• Product Code: GCY
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1