MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BULK SURG PAT 1/2 X 2; OEM PATTIES & STRIPS

Catalog Number	245410
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
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
This is 3 of 4 reports linked to mfg report numbers: 3014334038-2024-00023, 3014334038-2024-00024, 3014334038-2024-00026.A facility reported a hair was found in a surgical patty (id 245404) before a procedure, after the set-up process was complete and contaminated the entire set-up.There was a delay of approximately 60 minutes.The entire set up was discarded, the area was cleaned, and a new pack was opened.
Additional Manufacturer Narrative
The surgical patty (id (b)(6) was returned for evaluation.Device history record (dhr) - the batch record was reviewed for any anomalies or noncompliance related to the finished device, and none were identified.Failure analysis - one unpackaged card was returned.No hair was present on the patties or the card.No hair was found in the sealed medline sterilization pouch.Complaint cannot be confirmed.Root cause analysis - the report has not been confirmed as no particulate is present on the patties, card, or within the sterilization pouch.
Event or Problem Description
N/a.

• Brand Name: BULK SURG PAT 1/2 X 2
• Common Device Name: OEM PATTIES & STRIPS
• 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 08540 ; 6099362319
• MDR Report Key: 18695418
• Report Number: 3014334038-2024-00025
• Device Sequence Number: 20614752
• Product Code: HBA
• UDI-Device Identifier: 10381780513421
• UDI-Public: 10381780513421
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: 245410
• Device Lot Number: 6914940
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown