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

Model Number	801403
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
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 that after opening a set of surgical patties, a brownish spot was found on one of the patties.There was no patient contact.
Additional Manufacturer Narrative
The surgical pattie was not returned for failure analysis, but a photo was sent by the customer: dhr review: there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis: the pattie/strip photo was inspected using the unaided eye.The analyst confirmed the presence of a burn mark near the green string.The complaint could be verified through failure analysis.Root cause analysis: per the complaint background, brownish spot.The complaint was confirmed in the complaint investigation.Per the failure analyst, "cottonoid material is formed from rayon.During processing, this rayon material is broken down into small, loose fibers.If the fibers do not break down properly, a small cluster of fibers can result.This creates a thick spot in the pattie.When the string or x-ray is ultrasonically welded on this spot it absorbs more energy than the rest of the pattie and results in a burn.Patties created on the hybrid machines are visually inspected during the operator before being carded.Operators fan through the stack of 10 patties counting each pattie and ensuring there are no defects.They then flip over the stack and repeat before attaching the stack to a card.Because the burn mark was missed the complaint can be attributed to operator error.Operators identified in the lot traveler will be retrained to the complaint." a corrective action has been implemented to investigate the patties/strips product family.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The surgical pattie (801403) was returned for evaluation.Dhr review: there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis: the pattie/strip was inspected using the unaided eye.The analyst confirmed the presence of a burn mark near the green string.The complaint could be verified through failure analysis.Root cause: the complaint was confirmed in the complaint investigation.Per the failure analyst, ¿cottonoid material is formed from rayon.During processing, this rayon material is broken down into small, loose fibers.If the fibers do not break down properly, a small cluster of fibers can result.This creates a thick spot in the pattie.When the string or x-ray is ultrasonically welded on this spot it absorbs more energy than the rest of the pattie and results in a burn.Patties created on the hybrid machines are visually inspected during the operator before being carded.Operators fan through the stack of 10 patties counting each pattie and ensuring there are no defects.They then flip over the stack and repeat before attaching the stack to a card.Because the burn mark was missed the complaint can be attributed to operator error.Operators identified in the lot traveler will be retrained to the complaint.¿ 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.The risk remains acceptable per the risk analysis.There is an open corrective action to investigate the patties/strips product family.

• Brand Name: SURG PAT XRAY 1X1 -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: 13077346
• Report Number: 3014334038-2021-00264
• Device Sequence Number: 5824131
• Product Code: HBA
• UDI-Device Identifier: 10381780514992
• UDI-Public: 10381780514992
• 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,Followup
• Report Date (Section B): 05/25/2022

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 Expiration Date: 01/31/2026
• Device Model Number: 801403
• Device Catalogue Number: 801403
• Device Lot Number: 5140468
• 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: 12/03/2021
• Supplement Date Received by Manufacturer: 12/23/2021; 05/06/2022
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 01/19/2022; 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2021
• 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