MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD SILICONE CHANNEL DRAIN

Catalog Number 072221

Device Problems Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

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

Event Date 12/15/2014

Event Type  malfunction  

Event Description

It was reported that the device was unable to drain.Another device was used to complete the procedure.After the sample was received at the manufacturing site, the drain was dissected from the connector-drainbonding for evaluation under 10 x magnification and occlusion with adhesive between the drain and the connector was found.

Manufacturer Narrative

Received 1 used silicone channel drain.Visual inspection found no obvious defects, no manufacturing deficiencies were observed, body residues were found along the returned device.Per functional evaluation, water did not pass through the drain channels, under 10x magnification occlusion with adhesive between the drain and connector was found.The drain was measured and determined to be out of specification due to the fact that the rest of the drain was not returned.The reported event was confirmed as manufacturing related.The lot number is unknown therefore a device history record could not be reviewed.(b)(4).

• Brand Name: SILICONE CHANNEL DRAIN
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD; nogales, sonora ; MX
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD; km.7 carretera internacional; nogales, sonora 8562 1; MX 85621
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4534668
• MDR Text Key: 5508834
• Report Number: 1018233-2015-00038
• Device Sequence Number: 1
• Product Code: GBX
• 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: Foreign
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/22/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 072221
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2015
• Initial Date FDA Received: 02/13/2015
• 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