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

Catalog Number	0115410
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	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the onflex mesh was noted to be contaminated with foreign matter.The sample was not returned for review and no additional information has been provided.Based on the information available and without having the sample to evaluate, no conclusions can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.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, onflex mesh contaminated with foreign matter.There was no patient involvement.
Additional Manufacturer Narrative
As reported, the onflex mesh was noted to be contaminated with foreign matter.The sample was not returned for review and no additional information has been provided.Based on the information available and without having the sample to evaluate, no conclusions can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this supplemental mdr is submitted to document the sample evaluation results.Received for evaluation was the opened onflex mesh product carton, inside the carton was the onflex mesh which was contained within the sealed inner sterile foil pouch.Evaluation of the returned sample finds no foreign matter/object on or within the product carton or on the inner sterile foil pouch.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) released for distribution in june 2023.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, onflex mesh contaminated with foreign matter.There was no patient involvement.

• Brand Name: ONFLEX
• 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: 19459765
• Report Number: 1213643-2024-00283
• Device Sequence Number: 6735381
• Product Code: FTL
• UDI-Device Identifier: 00801741074424
• UDI-Public: (01)00801741074424
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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: 04/28/2026
• Device Catalogue Number: 0115410
• Device Lot Number: HUHS0375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2023
• 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