MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 SILICONE CHANNEL DRAIN WITHOUT TROCAR, 19 FR., ROUND HUBLESS, FULL FLUTED

Catalog Number V072230

Device Problem Fitting Problem (2183)

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

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 size of the channel drain was larger than devices previously used (072230), and would not fit on the bulb.The user stated there is a visible difference in diameter when the drains are next to each other.

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: " drain placement and the fr size is indicated: reorder #: drain size: drain shape: fluting trocar depth indicator: v072230, 19 fr.Round hubless, full ¿, dot.V072234, 24 fr.Round hubless full ¿ dot." (b)(4).The device was not returned.

Event Description

It was reported that the size of the channel drain was larger than devices previously used (b)(4), and would not fit on the bulb.The user stated there was a visible difference in diameter when the drains were next to each other.

• Brand Name: SILICONE CHANNEL DRAIN WITHOUT TROCAR, 19 FR., ROUND HUBLESS, FULL FLUTED
• Type of Device: CHANNEL DRAIN
• 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: 6679850
• MDR Text Key: 78904507
• Report Number: 1018233-2017-03405
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741051616
• UDI-Public: (01)00801741051616
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: V072230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 06/29/2017
• Supplement Dates Manufacturer Received: 06/30/2017
• Supplement Dates FDA Received: 07/12/2017
• 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