MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE SYRINGE 5-PACK, 2ML; GLUE,SURGICAL,ARTERIES

Model Number BG3502-5-G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Fluid Discharge (2686)

Event Date 10/08/2021

Event Type  Injury  

Event Description

According to the initial report, "surgeon had use bioglue2ml for dural sealant to prevent csf leakage procedure 2 months ago and patient came back to follow up again.The healing process looked good but it's seem some infection fluid leakage from their skin but it's not an infection because all patients had no fever and all delayed fluid collection were reported "no growth" after fluid culture.Then the surgeon had to re-operation to remove fluid and bg that probably the cause of the fluid.The surgeon said he had a experience with bg about to remove from the patients who used it more than 2 years and its seem not absorb to their body of patients and the issue of them occurred same as this case.The surgeon found that the patients 20-30% who use bg usually came back to remove bg from cause of fluid leaked for their skin and need to re-operation again.Surgeon strongly believed that it was not infectious process, but it should be some kind of allergic reaction to the component in bioglue.Bg probably cause of fluid leakage seem like infection and need to remove from patients skin or re-operation and move bg from their body." patient no.1 came to see a surgeon for swelling behind his right ear 3 weeks later after his operation with bg 6 weeks ago.So the doctor had to remove some fluid from his swelling, it seem like an infection fluid but patient had no fever and all delayed fluid collection were reported "no growth" after fluid culture.Patient no.2 had an operation with bg on (b)(6) 2021 and today ((b)(6) 2021) he came to consult about his surgical wound had a lymphatic drainage for 1 week , he had no fever and all delayed fluid collection were reported "no growth" after fluid culture as well.

Event Description

According to the initial report, "surgeon had use bioglue2ml for dural sealant to prevent csf leakage procedure 2 months ago and patient came back to follow up again.The healing process looked good but it's seem some infection fluid leakage from their skin but it's not an infection because all patients had no fever and all delayed fluid collection were reported "no growth" after fluid culture.Then the surgeon had to re-operation to remove fluid and bg that probably the cause of the fluid.The surgeon said he had a experience with bg about to remove from the patients who used it more than 2 years and its seem not absorb to their body of patients and the issue of them occurred same as this case.The surgeon found that the patients 20-30% who use bg usually came back to remove bg from cause of fluid leaked for their skin and need to re-operation again.Surgeon strongly believed that it was not infectious process, but it should be some kind of allergic reaction to the component in bioglue.Bg probably cause of fluid leakage seem like infection and need to remove form patients skin or re-operation and move bg from their body." patient no.1 came to see a surgeon for swelling behind his right ear 3 weeks later after his operation with bg 6 weeks ago.So the doctor had to remove some fluid from his swelling, it seem like an infection fluid but patient had no fever and all delayed fluid collection were reported "no growth" after fluid culture.Patient no.2 had an operation with bg since (b)(6) 2021 and today ((b)(6) 2021) he came to consult about his surgical wound had a lymphatic drainage for 1 week , he had no fever and all delayed fluid collection were reported "no growth" after fluid culture as well.

• Brand Name: BIOGLUE SYRINGE 5-PACK, 2ML
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 12773820
• MDR Text Key: 284832876
• Report Number: 1063481-2021-00034
• Device Sequence Number: 1
• Product Code: MUQ
• UDI-Device Identifier: 00877234005121
• UDI-Public: 877234005121
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

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 Expiration Date: 03/28/2022
• Device Model Number: BG3502-5-G
• Device Lot Number: BG000077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/09/2021
• Initial Date Manufacturer Received: 10/09/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 10/09/2021
• Supplement Dates FDA Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other