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

Catalog Number	1200710
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	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a foreign material (hair) found while opening the phasix st mesh package.Photo review confirms the foreign material (hair) present on the inner protective sleeve.The physical sample has been returned for evaluation.The root cause investigation is currently ongoing.When sample evaluation is completed, a supplemental emdr will be submitted.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of 365 units released for distribution in february 2024.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, during a hiatal hernia repair procedure, while opening the phasix st mesh a foreign material (hair) was found in the inner sterile package.It was reported that a new phasix st mesh was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
As reported, a foreign material (hair) found while opening the phasix st mesh package.Photo review confirms the foreign material (hair) present on the inner protective sleeve.The physical sample has been returned for evaluation.The root cause investigation is currently ongoing.When sample evaluation is completed, a supplemental emdr will be submitted.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) released for distribution in february 2024.Addendum: this supplemental mdr is submitted to document the sample evaluation results.Sample evaluation confirmed a foreign matter (human hair) found inside the tyvek envelope.Based on sample and manufacturing process evaluation performed, the root cause is confirmed as manufacturing related.Awareness notification was provided to all appropriate personnel.Our records continue to show there have been no other reported complaints to date for this lot of 365 units released for distribution in february 2024.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, during a hiatal hernia repair procedure, while opening the phasix st mesh a foreign material (hair) was found in the inner sterile package.It was reported that a new phasix st mesh was used to complete the procedure.There was no patient injury.

• Brand Name: PHASIX ST 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: 19371404
• Report Number: 1213643-2024-00265
• Device Sequence Number: 15337961
• Product Code: OWT
• UDI-Device Identifier: 00801741095337
• UDI-Public: (01)00801741095337
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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 Expiration Date: 08/28/2026
• Device Catalogue Number: 1200710
• Device Lot Number: HUHZ0165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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