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

Catalog Number	0070850
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2017
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 identified foreign material on the device.The foreign material allegedly appeared to resemble mold, and was attached inside of the suction evacuator.The foreign material was identified as the user attempted to use the device.
Additional Manufacturer Narrative
The reported issue (the user found something white that looked like mold attached inside of the suction evacuator as the user attempted to use the device) was confirmed.The device was returned.The visual inspection noted foreign material inside the evacuator, this foreign material was silicone residue not mold.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state 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 identified foreign material on the device.The foreign material allegedly appeared to resemble mold, and was attached inside of the suction evacuator.The foreign material was identified as the user attempted to use the device.

• Brand Name: RELIAVAC 100 CLOSED WOUND SUCTION EVACUATOR, 100ML CAPACITY, MEDIUM SUCTION
• 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: 6487683
• Report Number: 1018233-2017-01751
• Device Sequence Number: 1641904
• Product Code: GCY
• UDI-Device Identifier: 00801741049613
• UDI-Public: (01)00801741049613(10)NGAR0485
• 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): 07/26/2017

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 Expiration Date: 04/30/2021
• Device Catalogue Number: 0070850
• Device Lot Number: NGAR0485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 07/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1