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

Catalog Number	0115610
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	12/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, upon opening the package of modified onflex mesh, a foreign material like hair was found.The subject device has been returned for evaluation.However, the sample evaluation is currently ongoing.When the sample evaluation has been completed a supplemental emdr will be submitted.Review of manufacturing records shows the product was manufactured to specification.
Event or Problem Description
As reported on (b)(6) 2022, upon opening the bard/davol modified onflex mesh package, a foreign material like hair was found.It was reported that another mesh was used to complete the procedure and there was no reported patient injury.
Event or Problem Description
As reported on (b)(6) 2022, upon opening the bard/davol modified onflex mesh package, a foreign material like hair was found.It was reported that another mesh was used to complete the procedure and there was no reported patient injury.
Additional Manufacturer Narrative
As reported, upon opening the package of modified onflex mesh, a foreign material like hair was found.The subject device has been returned for evaluation.However, the sample evaluation is currently ongoing.When the sample evaluation has been completed a supplemental emdr will be submitted.Review of manufacturing records shows the product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in april 2022.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the sample evaluation results.Evaluation of the sample finds upon opening the tyvek envelope a foreign material (hair) is present within the envelope as reported.Investigation finds the condition may have originated at manufacturing area during sealing/ inner packaging manufacturing process (since hair like foreign matter was found inside the tyvek envelope).Based on the sample evaluation and investigation performed, the root cause of the reported event was determined to be manufacturing related.Awareness notification 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.H3 other text : sample evaluated.

• Brand Name: MODIFIED 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: 16050668
• Report Number: 1213643-2022-00820
• Device Sequence Number: 6083130
• Product Code: FTL
• UDI-Device Identifier: 00801741095399
• UDI-Public: (01)00801741095399
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142706
• 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): 01/02/2023

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 Expiration Date: 01/28/2025
• Device Catalogue Number: 0115610
• Device Lot Number: HUGP0847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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