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

Catalog Number V072230

Device Problem Device Markings/Labelling Problem (2911)

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.

Event Description

It was reported that the packaging was labeled as a 19fr.Device; however, the device inside was allegedly larger than 19fr.

Manufacturer Narrative

The reported issue (the packaging was labeled to be a 19fr drain; the device inside reportedly was bigger than 19fr) was confirmed.The device was returned and was visually inspected, however there were no noted obvious defects.Per dimensional evaluation the (2) two samples were measured with a french scale and optical comparator.The two samples were confirmed that correspond to one piece channel drain 24fr.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: ¿ 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).

Event Description

It was reported that the packaging was labeled as a 19fr.Device; however, the device inside was allegedly larger than 19fr.

• Brand Name: SILICONE CHANNEL DRAIN WITHOUT TROCAR, 19 FR., ROUND HUBLESS, FULL FLUTED
• Type of Device: 19FR SILICONE 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: 6593004
• MDR Text Key: 76134059
• Report Number: 1018233-2017-02687
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741051616
• UDI-Public: (01)00801741051616(10)NGAZ3014
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: V072230
• Device Lot Number: NGAZ3014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• 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