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

Catalog Number	1193535
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial evaluation of returned sample confirms the reported condition.Investigation is in process.The review of manufacturing records shows 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 march 2023.A supplemental mdr will be submitted once the evaluation has been completed.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.
Event or Problem Description
As reported, the outer box of the phasix flat mesh was opened and found that there was a hole in the inside sterile packaging (small tear in foil pouch).Another phasix mesh was used to complete the procedure.As reported the outer carton had not been opened prior and there was no damage noted to the outer carton.There was no patient impact.
Event or Problem Description
As reported, the outer box of the phasix flat mesh was opened and found that there was a hole in the inside sterile packaging (small tear in foil pouch).Another phasix mesh was used to complete the procedure.As reported the outer carton had not been opened prior and there was no damage noted to the outer carton.There was no patient impact.
Additional Manufacturer Narrative
Initial evaluation of returned sample confirms the reported condition.Investigation is in process.The review of manufacturing records shows 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 march 2023.A supplemental mdr will be submitted once the evaluation has been completed.Addendum: this supplemental mdr is submitted to document the sample evaluation results.Received for evaluation was the outer carton (opened), and the inner sterile foil pouch (unopened).The outer carton was creased/bent.There is a hole/tear present on the front side of the inner sterile foil pouch and breach to the package.The foil hole/tear direction is inward, as a suggestion of an object causing the perforation.The reported event could not be replicated during assessment performed.A root cause for hole/tear observed could not be determined at this time.Our records continue to show this is the only reported complaint for this lot.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.

• Brand Name: PHASIX 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: 19341809
• Report Number: 1213643-2024-00263
• Device Sequence Number: 21004482
• Product Code: OOD
• UDI-Device Identifier: 00801741107665
• UDI-Public: (01)00801741107665
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2024

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: 11/28/2024
• Device Catalogue Number: 1193535
• Device Lot Number: HUGZ0349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• 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