MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 RELIAVAC 100 CLOSED WOUND SUCTION EVACUATOR, 100ML CAPACITY, LOW SUCTION, 36IN

Catalog Number	0070900
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/31/2017
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 user found a crack on the junction of the suction evacuator and the y connector prior to use.Additional information has been requested.
Additional Manufacturer Narrative
Received a evacuator without of its original package.The reported event was confirmed with an unknown cause.During the visual evaluation, it was observed that the blue cap (cm50021) of the evacuator had a crack.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "do not use if package is damaged.Consult instructions for use." 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 user found a crack on the junction of the suction evacuator and the y connector prior to use.Additional information has been requested.

• Brand Name: RELIAVAC 100 CLOSED WOUND SUCTION EVACUATOR, 100ML CAPACITY, LOW SUCTION, 36IN
• Common Device Name: SUCTION EVACUATOR
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• MDR Report Key: 6517472
• Report Number: 1018233-2017-02011
• Device Sequence Number: 6341
• Product Code: GCY
• UDI-Device Identifier: 00801741049620
• UDI-Public: (01)00801741049620
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2017

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 Catalogue Number: 0070900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1