MAUDE Adverse Event Report: RAYNHAM BULK SURG STRIP 1/4 X 6; OEM PATTIES & STRIPS

Model Number	245431
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 "dirt" on a pattie strip (id 245431).No patient injury reported.No additional information provided after several attempts.
Additional Manufacturer Narrative
The surgical strip (id 245431) was not returned for evaluation but a photo was provided: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the failure analyst viewed the photo and confirmed that there is discoloration present on the strip.Root cause - the complaint was confirmed in the complaint investigation.Per failure analyst: ¿when cottonoid is produced, rayon bales are broken down into small fibers and woven into sheets.These sheets are then saturated with a binder material and put through an oven.The binder material can become burnt and build up in the oven.When the built up binder makes contact with the sheet of fiber it can cause discoloration.Strips are visually inspected by operators who fan through the stack of 10 strips counting each one and ensuring there are no defects.They then flip over the stack and repeat this inspection.Because the contamination was missed the complaint can be attributed to operator error during assembly.Applicable operators will be retrained.¿ a corrective and preventative action (capa) has been closed in june 2022 for the patties/strips product family relate to discoloration, incorrect count, string issues, and x-ray detectability.The capa implemented preventative actions to minimize the issues reported.

• Brand Name: BULK SURG STRIP 1/4 X 6
• Common Device Name: OEM PATTIES & STRIPS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16765810
• Report Number: 3014334038-2023-00051
• Device Sequence Number: 12270541
• Product Code: HBA
• UDI-Device Identifier: 10381780513469
• UDI-Public: 10381780513469
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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 Model Number: 245431
• Device Catalogue Number: 245431
• Device Lot Number: 6416696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 06/09/2023
• Date Device Manufactured: 07/06/2022
• 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