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

Model Number 5955600

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

The physical sample was not returned for evaluation.A photo of the echo ps and the piece of material removed from the abdomen was provided.The half moon shaped material is a residual portion of the echo ps balloon that is cut off and removed as part of the manufacturing process.It appears the piece of residual material was not removed during manufacture and was embedded in the echo ps assembly.The piece then appears to have came free during manipulation of the device while in use.The manufacturing process requires the removal of residual material that is cut off during manufacture.It appears that the residual material in question became lodged in the assembly, and went undetected during additional processing.Additional processing includes a visual inspection for this condition.We have confirmed the root cause to be related to the manufacturing process.A supplier notification was conducted.The lot (hubt2581) was manufactured in august, 2017.Lot qty.132 units, released for distribution in august, 2017.A review of the manufacturing records has been performed.No manufacturing issues associated to the reported event were found in the reviewed lot.All process steps were completed per manufacturing procedures, inspection procedures, as documented in the work order.Product passed all required inspections.To date there have been no other reported complaints for this manufacturing lot.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.Not returned.

Event Description

It was reported that on (b)(6) 2018 a hernia repair using a ventralight st with echo positioning system (ps) was performed.During an examination of the abdomen before the end of the procedure, a small half moon shaped portion of echo ps material was identified free within the abdomen.The fragment of material was removed from the patient's abdomen.Contact confirmed there was no patient injury or need for additional intervention as a result of this event.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 7500513
• MDR Text Key: 108111190
• Report Number: 1213643-2018-01408
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031731
• UDI-Public: (01)00801741031731
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K130968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: 5955600
• Device Catalogue Number: 5955600
• Device Lot Number: HUBT2581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2017
• 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