MAUDE Adverse Event Report: RAYNHAM SURG PAT XRAY 1/2X1 -200; SURGICAL PATTIES

Model Number	801402
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
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
It was reported a customer discovered a hair on a surgical pattie packaging prior to opening, before a procedure.No patient injury reported.
Additional Manufacturer Narrative
Complaint sample was received for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - complaint confirmed, hair present in sealed packaging.Root cause - product is made on a hybrid machine where an operator manually wraps the product on the card.The product is then manually placed in a sealer.The operations are performed in a iso class 8 cleanroom.The requirements for this environment include a hair-net and gown with long sleeves.The hair contaminating the product appears to be the type which would be contained by the hairnet.Hair contamination occurred during one of these two steps due to improper concealment of hair in hair net.Applicable operators will be retrained to hair gowning procedure.
Event or Problem Description
N/a.

• Brand Name: SURG PAT XRAY 1/2X1 -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: 15547259
• Report Number: 3014334038-2022-00225
• Device Sequence Number: 16611815
• Product Code: HBA
• UDI-Device Identifier: 10381780514985
• UDI-Public: 10381780514985
• 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): 10/26/2022

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: 801402
• Device Catalogue Number: 801402
• Device Lot Number: 5907868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2022
• 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