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

Catalog Number	0117010
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	03/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, before removing the product from the packaging, it was noted that there was a hair in the inner packaging.The mesh was not used to perform a procedure and another mesh was then used.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, there was a hair in the soft mesh inner packaging.Photo evaluation find what appears to be foreign material (hair-like, black) within the sterile pouch.Photo review does not assist in determining root cause.The sample is reported to be available for return, however, has not been received at this time.Based on the information reported and without having the physical sample to evaluate, no conclusions can be made.If/when the sample is returned and evaluation has been completed, a supplemental mdr will be submitted to document the results.Review of the manufacturing records was performed and found the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 201 units released for the distribution in september 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.
Additional Manufacturer Narrative
As reported, there was a hair in the soft mesh inner packaging.Photo evaluation find what appears to be foreign material (hair-like, black) within the sterile pouch.Photo review does not assist in determining root cause.The sample is reported to be available for return, however, has not been received at this time.Based on the information reported and without having the physical sample to evaluate, no conclusions can be made.If/when the sample is returned and evaluation has been completed, a supplemental mdr will be submitted to document the results.Review of the manufacturing records was performed and found the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for the distribution in september 2023.Addendum: this is an addendum to the initial mdr and is submitted to document the sample evaluation results.Sample evaluation confirmed a thread-like foreign matter black in color inside of the tyvek envelope.Based on the sample evaluation and investigation performed, root cause is determined to be a manufacturing-generated condition.Be assured, the issue has been addressed with the 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, before removing the product from the packaging, it was noted that there was a hair in the inner packaging.The mesh was not used to perform a procedure and another mesh was then used.There was no reported patient injury.

• Brand Name: BARD SOFT MESH
• 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: 19088275
• Report Number: 1213643-2024-00146
• Device Sequence Number: 17927336
• Product Code: FTL
• UDI-Device Identifier: 00801741030871
• UDI-Public: (01)00801741030871
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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 Catalogue Number: 0117010
• Device Lot Number: HUHV0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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