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

Catalog Number	0117320
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported on (b)(6) 2022 prior to opening the 3dmax light mesh clam shell tray a foreign material (hair like), was noted in the sterile product packaging.Another device was used to complete the laparoscopic inguinal hernia repair (tapp) procedure.There was no reported patient injury.
Additional Manufacturer Narrative
The physical sample was not provided for review; however, photos of the sample were provided.Initial review of the photos confirms the presence of a foreign material (appears to be hair) within the inner clam shell tray.At this time, the investigation is ongoing, and root cause has not been established.A supplemental emdr will be submitted upon completion of the investigation.Review of manufacturing records confirms product was made to specification.To date, this is the only reported complaint for this manufacturing lot of 679 units released for distribution in may 2022.Not returned.
Additional Manufacturer Narrative
The physical sample was not provided for review; however, photos of the sample were provided.Initial review of the photos confirms the presence of a foreign material (appears to be hair) within the inner clam shell tray.At this time, the investigation is ongoing, and root cause has not been established.A supplemental emdr will be submitted upon completion of the investigation.Review of manufacturing records confirms product was made to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in may 2022.Addendum: this supplemental mdr is submitted to document the completion of the photo evaluation.Evaluation of the photo provided confirms there is hair like foreign material present within the clam shell tray.Based on the photo evaluation and investigation performed, root cause is determined to be manufacturing related.Awareness training was provided to appropriate manufacturing personnel.Note: section a through f - 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 on (b)(6) 2022 prior to opening the 3dmax light mesh clam shell tray a foreign material (hair like), was noted in the sterile product packaging.Another device was used to complete the laparoscopic inguinal hernia repair (tapp) procedure.There was no reported patient injury.

• Brand Name: 3DMAX LIGHT
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 15835408
• Report Number: 1213643-2022-00755
• Device Sequence Number: 5762041
• Product Code: FTL
• UDI-Device Identifier: 00801741031052
• UDI-Public: (01)00801741031052
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023

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 Catalogue Number: 0117320
• Device Lot Number: HUGR1565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown