MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO

Catalog Number 5955680

Device Problems Improper or Incorrect Procedure or Method (2017); Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/10/2014

Event Type  malfunction  

Event Description

The following was reported to a davol sales rep: on (b)(6) 2014 towards the end of a surgical procedure one of the four inflation device connectors could not be accounted for after removal.The surgical team looked for the connector, however they could not locate it.While not confirmed, the connector is believed to have been possibly left inside the pt's abdominal cavity.There was no reported adverse pt outcome as a result of this event.As an unintended portion of the device was possibly left in vivo an mdr is being submitted to document this event.

Manufacturer Narrative

• Brand Name: VENTRALIGHT ST W/ ECHO
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; warwick RI
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, rd #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossings blvd; warwick, RI 02886 ; 8005566756
• MDR Report Key: 4001843
• MDR Text Key: 4708165
• Report Number: 1213643-2014-00206
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2014

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 Expiration Date: 04/30/2016
• Device Catalogue Number: 5955680
• Device Lot Number: HUYD0301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2014
• Initial Date FDA Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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