MAUDE Adverse Event Report: RAYNHAM SURG PAT XRAY 1/2X3 -200; SURGICAL PATTIES

Catalog Number	801407
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a surgical pattie (id 801407) has a missing string in pack.During the case, the surgeon removed patties from the nose (sinus surgery).Noted that a pattie remained in the nose and the string had detached from the pattie.Pattie was removed from the surgical site.Count was correct at the end of case.Additionally, the customer stated "patties were noticed to deteriorate during case.No patient injury reported.
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.
Additional Manufacturer Narrative
The surgical patties (b)(4).Was not returned for evaluation as the product is not available for return as per customer; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.Additional information received: 1.Were the patties irrigated during use? >>> patties were coated with our local solution (cocaine 10%in 2mls w/sodium bicarbonate 7mls and adrenaline 1:1000/1ml).We don¿t typically use irrigation whilst the patties are in the patient.2.Were the patties moistened prior to use? if yes, how long? >>> patties are moistened prior to use in our local solution.Patties are used before and during the procedure.Patties are normally soaked during the patient¿s intubation (approx.10-15mins before use).However, one of the patties was noted to be missing the string prior to being soaked in the local solution.This was removed from the sterile field and placed aside as the remaining patties had appeared to have strings attached.3.Was the product altered or cut from the original size prior to use? >>> product was not altered or cut.
Event or Problem Description
N/a.

• Brand Name: SURG PAT XRAY 1/2X3 -200
• Common Device Name: SURGICAL PATTIES
• 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: 17305528
• Report Number: 3014334038-2023-00111
• Device Sequence Number: 7184904
• Product Code: HBA
• UDI-Device Identifier: 10381780515029
• UDI-Public: 10381780515029
• 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): 07/28/2023

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 Catalogue Number: 801407
• Device Lot Number: 6788537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 07/28/2023
• Date Device Manufactured: 12/12/2022
• 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