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
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 packaging was labeled as a 19fr.Device; however, the device inside was allegedly larger than 19fr.
Additional Manufacturer Narrative
The reported issue (it was reported that the packaging was labeled for a 19fr device; but the size of the device was bigger than 19fr) was confirmed.The sample was returned and visually inspected, and noted no obvious defects.Per dimensional evaluation the sample was measured with french scale and optical comparator.The sample was confirmed to correspond with one piece 24fr channel drain.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: ¿drain placement and the fr size is indicated: reorder #v072230 19 fr., drain size: round hubless; drain shape: full ¿; fluting: dot; trocar depth indicator.V072234 24 fr., round hubless, full ¿, dot." (b)(4).
Event or Problem 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
• Common Device Name: 19FR SILICONE CHANNEL DRAIN
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• MDR Report Key: 6592972
• Report Number: 1018233-2017-02683
• Device Sequence Number: 18888608
• Product Code: GBX
• UDI-Device Identifier: 00801741051616
• UDI-Public: (01)00801741051616(10)NGAZ3014
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2017

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: 01/31/2022
• Device Catalogue Number: V072230
• Device Lot Number: NGAZ3014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1