MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX MID; SURGICAL MESH

Catalog Number	0116312
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a brown fiber was found on the 3dmax mid mesh.At this time, no conclusion can be made.While the sample evaluation is anticipated, it has not get begun.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 165 units released for distribution in september 2020.When sample evaluation is completed, a supplemental emdr will be submitted.The information provided by bd 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 bd.
Event or Problem Description
As reported, during a robotic inguinal case on (b)(6) 2020, it was identified that a brown fiber was found on the 3dmax mid xl.The issue was noticed when the sterile packaging was opened prior to handing off to the or nurse in the sterile field.As reported, the mesh was not used, another mesh was brought into the case and the procedure was successfully completed.There was no reported patient injury.
Event or Problem Description
As reported, during a robotic inguinal case on (b)(6) 2020, it was identified that a brown fiber was found on the 3dmax mid xl.The issue was noticed when the sterile packaging was opened prior to handing off to the or nurse in the sterile field.As reported, the mesh was not used, another mesh was brought into the case and the procedure was successfully completed.There was no reported patient injury.
Additional Manufacturer Narrative
It was reported that a brown fiber was found on the 3dmax mid mesh.At this time, no conclusion can be made.While the sample evaluation is anticipated, it has not get begun.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 165 units released for distribution in september 2020.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of the device evaluation.The subject device was returned for evaluation.Visual inspection identified a brown fiber/ particle enclosed within the clam shell tray.Based on the investigation activities performed, the reported event is confirmed for foreign matter inside the sealed package.As the foreign matter was present in the package prior to sealing, this presented at the time of manufacturing and is confirmed for a manufacturing related condition.Sample evaluated.

• Brand Name: 3DMAX MID
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10919424
• Report Number: 1213643-2020-20060
• Device Sequence Number: 1429475
• Product Code: FTL
• UDI-Device Identifier: 00801741200762
• UDI-Public: (01)00801741200762
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K200818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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: 05/28/2022
• Device Catalogue Number: 0116312
• Device Lot Number: HUETAB07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 11/30/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other