MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 CLOSED WOUND SUCTION EVACUATOR, 100ML SILICONE EVACUATOR WITH ANTI; RELIA VAC

Catalog Number 0070740

Device Problem Device Inoperable (1663)

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

Event Date 10/17/2016

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.

Event Description

It was reported that the suction evacuator would not aspirate during pretest.

Manufacturer Narrative

Received 1 pretested wound suction evacuator only.The reported issue was confirmed; however, the cause in unknown.During visual inspection noted that the retaining ring was disconnected, no missing pieces were found.Evidence that the retaining ring had been assembled to the evacuator's bulb was noted.Evidence of this assembly is usually noted with a mark on the bottom part of the silicone bulb.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: an airtight seal between all system components (drain, adapter, y-connector, crab-claw, evacuator and tube ends) is necessary for intended system function.".

Event Description

It was reported that the suction evacuator would not aspirate during pretest.Per sample evaluation, the suction evacuator failed to suction due to a disconnection between the seal of the valve and the evacuator body.

• Brand Name: CLOSED WOUND SUCTION EVACUATOR, 100ML SILICONE EVACUATOR WITH ANTI
• Type of Device: RELIA VAC
• 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: 6482938
• MDR Text Key: 72673035
• Report Number: 1018233-2017-01683
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741049569
• UDI-Public: (01)00801741049569
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0070740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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