MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S; SURGIFLO¿ HEMOSTATIC MATRIX KIT WITH THROMBIN

Lot Number	275391
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the very limited available information this case is considered a near adverse event (if the event occurred again, it could become a serious event).No patient harm was reported.
Event or Problem Description
It was reported by the account contact that during a c-section procedure that while mixing the sterile "water" was leaking out of the top needing more sterile "water" to be added.The product was used on the patient and once handed back to the surgical tech it was found that there was a chip glass along the rim of the vial.The surgeon was informed but the product had already been used on the patient.There were no adverse consequences reported.No device returning for evaluation.The nurse request a vial of sterile water pulled from the pyxis and pulled the extra water needed from that to add to finish mixing.The chip was on the thrombin vial is self around the edge where the metal ring is.The thrombin vial was not in contact with the patient.The nurse noticed the chip on the vial when getting ready to discard the empty vial after the medication was mixed and administered by the surgeon.The nurse notified the surgeon right away but the surgeon had administered it already.

• Common Device Name: SURGIFLO¿ HEMOSTATIC MATRIX KIT WITH THROMBIN
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, 2860 ; DA 2860
• Manufacturer Contact: . . ; sydmarken 5; soeborg, 2860 ; DA 2860
• MDR Report Key: 19905084
• Report Number: 3008478369-2024-00027
• Device Sequence Number: 15636388
• Product Code: LMF
• UDI-Device Identifier: 25712123000285
• UDI-Public: 25712123000285
• Combination Product (Y/N): Y
• PMA/510(K) Number: P990004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 275391
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown