MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SURG PATXRAY 1/2X1/2-200; SURGICAL PATTIES

Catalog Number	801400
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
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
A facility reported a hair was found inside sterile packaging of a surgical patty id (b)(6).The issue occurred pre-surgery, no patient contact/injury and the event did not led to surgical delay.The procedure was completed with a replacement product available.
Additional Manufacturer Narrative
The surgical patty (id 801400) was returned for evaluation.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - a large hair was confirmed to be contained within the blister.The complaint could be verified through failure analysis.Root cause analysis ¿ the complaint was confirmed in the complaint investigation.The root cause is attributed to improper use of a hair net.

• Brand Name: SURG PATXRAY 1/2X1/2-200
• Common Device Name: SURGICAL PATTIES
• 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: 17868756
• Report Number: 3014334038-2023-00163
• Device Sequence Number: 7490607
• Product Code: HBA
• UDI-Device Identifier: 10381780514961
• UDI-Public: 10381780514961
• Combination Product (Y/N): N
• PMA/510(K) Number: K880402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2024

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 Catalogue Number: 801400
• Device Lot Number: 7055783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown