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

Model Number	801404
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgical pattie was not returned for evaluation but a photo was provided showing the hair present on the patties.The complaint could be verified through failure analysis.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.Dhr: there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Currently the complaint issue does not represent an adverse trend, however the issue will continue to be monitored and trended through the complaint evaluation process.
Event or Problem Description
A distributor reported the surgical pattie was sealed with a hair inside.Issue was detected during inspection at the distribution site.

• Brand Name: SURG PAT XRAY 1/2X1 1/2
• Common Device Name: SURGICAL PATTIES
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• MDR Report Key: 12512493
• Report Number: 3014334038-2021-00198
• Device Sequence Number: 5122010
• Product Code: HBA
• UDI-Device Identifier: 10381780515005
• UDI-Public: 10381780515005
• 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: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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: Other
• Device Expiration Date: 01/31/2026
• Device Model Number: 801404
• Device Catalogue Number: 801404
• Device Lot Number: 5140452
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1