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

Catalog Number	1161015
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	04/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the inner sterile package of the xenmatrix graft was found to be torn when opened for a case.It is reported that the subject device is not available to be returned for evaluation.Review of manufacturing records confirms product was manufactured to specification.Based on the information available and without having the sample to evaluate, the reported condition of the packaging cannot be confirmed and/or root cause determined.This mdr represents device #1, additional mdrs were submitted to represent xenmatrix grafts device #2, device #3, and device #4.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 : not returned.
Event or Problem Description
As reported, when opened for a case it was noted that the inner sterile package of the xenmatrix graft (device #1) was torn.As reported the product box was completely sealed prior to opening for the case.The device was not used on the patient, the procedure was completed by using a new device.As reported, a quality check was completed and identified three additional xenmatrix grafts (device #2, device #3 and device #4) were found to have the same issue.
Additional Manufacturer Narrative
As reported, the inner sterile package of the xenmatrix graft was found to be torn when opened for a case.It is reported that the subject device is not available to be returned for evaluation.Review of manufacturing records confirms product was manufactured to specification.Based on the information available and without having the sample to evaluate, the reported condition of the packaging cannot be confirmed and/or root cause determined.Addendum: this supplemental mdr is submitted to document the sample evaluation results of device #1 and additional supplemental mdrs were submitted to represent xenmatrix grafts device #2, device #3, and device #4.Visual examination of the pouch was performed finding a small tear in the foil pouch at one of the two manufacturer notches.These notches allow for ease of opening of the foil pouch.Visual inspection found no other anomalies.The tear found at the manufacture notch does not result in a breach of the sterile barrier.The tear noted is alleged to be an out of the box condition.As received the pouch was handled as evident by removal of a patient traceability label from the product pouch labeling.Based on sample and manufacturing process evaluation performed, a definitive root cause could not be determined, the reported condition potentially occurred at some instance after the product completed the manufacturing activities at the facility.The warning section of the instructions-for-use (ifu), supplied with the device states, "prior to use, carefully examine package and product to verify neither is damaged and that all seals are intact.Do not use if the package is damaged or open, or if the center of the temperature indicator on the foil pouch is black." updated fields: b4, d9, g2, g3, g6, h2, h3, h6, h10.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, when opened for a case it was noted that the inner sterile package of the xenmatrix graft (device #1) was torn.As reported the product box was completely sealed prior to opening for the case.The device was not used on the patient, the procedure was completed by using a new device.As reported, a quality check was completed and identified three additional xenmatrix grafts (device #2, device #3 and device #4) were found to have the same issue.

• Brand Name: XENMATRIX
• Common Device Name: PORCINE 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: 16969766
• Report Number: 1213643-2023-00199
• Device Sequence Number: 5580705
• Product Code: FTM
• UDI-Device Identifier: 00801741031380
• UDI-Public: (01)00801741031380
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2023

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: 07/28/2024
• Device Catalogue Number: 1161015
• Device Lot Number: HUGV0071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2022
• 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