MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MILTEX BIOPBLADE 50 PER BOX; M3 - DERMAL

Catalog Number	33-100
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
It was reported that as the physician was prepping for a procedure/organizing her procedure cart, the dermablade/miltex biopblade (b)(4) per box (33-100) positioned itself in the packaging somehow where it cut through the packaging.The provider was cut, incurred a laceration and required stitches for the wound.There was no delay in procedure or patient adverse consequence as a result of the incident.
Additional Manufacturer Narrative
Corrected field: g3 of initial mdr should read 06dec2023.G3 of initial mdr was erroneously submitted with aware date of 15dec2023.The aware date should have read 06dec2023 as we received "additional information" indicating that this case was first reported in an email to an integra representative on 06dec2023.
Additional Manufacturer Narrative
Supplier evaluation results: although the product was not returned for evaluation, the supplier was able to confirm the reported damage to the sterile pouch based on the photos provided.The manufacturing inspection record for this lot was checked and the supplier could not confirm that there was any equipment abnormality or manufacturing defects that could have led to this incident.Supplier investigation could not identify a root cause related to manufacturing or shipping.Per the product supplier, specification change is ongoing to convert to blister packaging.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated field: d4 (udi#), d9, g3, g6, h2, h3, h4, h6, h10 the suspected miltex biopblade (33-100) was not returned for evaluation.Device history record (dhr) review was conducted and no abnormalities related to the reported issue were identified.Searching this product id in our complaint handling system, no additional instances of user or patient injury were identified.Failure analysis: per visual evaluation of images/photos provided by the customer, the 33-100 blade cut through its sterile pouch packaging while being opened and cut the user.Root cause: the reported complaint was confirmed.Per the product supplier, validation is underway to convert the current packaging from sterile pouches to blister packs.As a result, no further action or investigation planned at this time.

• Brand Name: MILTEX BIOPBLADE 50 PER BOX
• Common Device Name: M3 - DERMAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18490134
• Report Number: 3014334038-2024-00005
• Device Sequence Number: 14336040
• Product Code: GDX
• UDI-Device Identifier: 10381780064312
• UDI-Public: 10381780064312
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/15/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 33-100
• Device Lot Number: 19J01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 01/10/2024; 02/12/2024; 03/21/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 01/11/2024; 03/11/2024; 04/15/2024
• Date Device Manufactured: 10/01/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female